10 ms·

> There are literally no studies proving that the Pfizer or Moderna gene therapies are safe and effective, or even that they are safe or effective, at both trea

> There are literally no studies proving that the Pfizer or Moderna gene therapies are safe and effective, or even that they are safe or effective, at both treating and preventing the spread of COVID-19. This is... wildly incorrect.

mikeyouse 5y ago
Calling them gene therapies too.. wow. I hope the more science-literate proponents of IVM can appreciate how much it harms their case for the vast majority of IVM advocates to be this loud and wrong..
- acdha 5y ago
  > I hope the more science-literate proponents of IVM If they valued and were capable of reasoning about the science, they would not be “proponents” — they'd recognize the current scientific understanding (no known mechanism or benefits, significant side-effects) and wait for a solid study before recommending anything. The people you do see advocating it are almost always doing so for political or financial purposes and are thus unlikely to say anything critical since that'd be bad for business.
  - creddit 5y ago
    Ivermectin doesn’t really have significant side effects at appropriate doses. It’s quite safe. Don’t be fooled by overblown “horse dewormer stories”. I don’t say this to advocate Ivermectin, the only RCT I know of/trust found absolutely no effect. I say this to gently point out the mismatch between your claims and the premise in the first sentence.
    - fullstop 5y ago
      I agree that it is safe at appropriate doses. The issue is that people are self medicating and incorrectly calculating doses, since the product was intended for livestock.
      - gonational 5y ago
        The nationwide report that everybody talked about, pertaining to poison control centers receiving endless calls about this was completely fake. It turned out that rather than 70% of calls it was actually 2% of calls and over half of them were simply people asking questions about dosage. The other nationwide report about the hospitals in Oklahoma being crowded with ivermectin victims to the point where they could not even get gunshot victims in to see a doctor... well, at least one of the hospital systems responded with an open letter stating that this was completely fake and that they had not seen even a single patient. I find it hard to believe that one hospital system would not see a single patient while all the other hospitals in the state would be completely flooded with them. If the TV tells you something, you do not have to believe it. Use your brain.
        fullstop 5y ago
        I never said a word about any of that. I said that people are self medicating and incorrectly calculating an appropriate dosage, and I am not wrong. [1] 1. https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 https://www.fda.gov/consumers/consumer-updates/why-you-shoul...
        gonational 5y ago
        What evidence did you have that people were doing this, which presumably affected your opinion on this topic?
        fullstop 5y ago
        1. Facebook groups where people have admitted to taking more than they should have, causing incontinence. Not public groups, but one local to my area. 2. The FDA themselves I have to ask, are you actually advocating for self-medicating with products from Tractor Supply? I've not once said anything about my opinion of Ivermectin, only that of self medication.
        5y ago
    - marcosdumay 5y ago
      Still, I don't think anybody talking about using ivermectin for treating COVID-19 ever recommended what is widely tested appropriate doses.
  - gonational 5y ago
    Yeah, because nothing says "recognize the current scientific understanding" like dismissing hundreds of studies because of a couple bunk meta-analysis. Also, nothing says "recognize the current scientific understanding" like injecting an untested medicine into your veins to avoid what amounts to the common cold for younger people; while ignoring the fact that it does not help prevent the spread, and according to the latest study on this from Israel (the highest vaccine rate in the world), actually enhances the spread, so if the argument is "what about the old people that you're going to infect", then I guess you've answered that question already. It pays nothing to pretend that you are smarter than other people if you're not willing to follow your own advice.
    - acdha 5y ago
      You're packing enough untrue things into that comment that it's hard to believe you're acting in good faith but: * It's dismissing the studies which show effects due to errors, which leaves the studies not showing beneficial effects. Science is built on evidence and thus far it hasn't been shown that Ivermectin has a benefit for COVID. * Similarly, it's untrue to the point of being a flagrant lie to claim that the vaccines are untested when they went through full clinical trials and the high positive effects and safety rates shown in those trials have been backed up by data from many millions of people * Similarly, it's flat out wrong to claim that COVID is similar to the common cold — even if you compare it to influenza, which is far more serious, that's not true — we've seen more children die in the last couple months than we typically see in an entire flu season. * Vaccination does help reduce the spread, and that's even shown in the Israeli data — it's not 100% but if you look at the data it's very clear that vaccinated people at a significantly lower rate. Israeli comparisons are tricky because they have substantially different vaccination rates across age categories and a vaccinated 80 year old is still more at risk than someone younger, especially when those younger people are not taking precautions, which brings me to: * Israel is nowhere near having the highest vaccine rate — that's a tie between Portugal, Malta, and the U.A.E. currently — and at a paltry 62% they're not even in the top 25. That's only slightly better than the United States at 55%. * The Iraeli data does not show that vaccination increases spread: this is a lie spread by people who are comparing unlike things in the knowledge that many people will reshare those claims without checking them.
  - JoshuaDavid 5y ago
    > If they valued and were capable of reasoning about the science, they would not be “proponents” — they'd recognize the current scientific understanding (no known mechanism or benefits, significant side-effects) and wait for a solid study before recommending anything. The the standard of "we should not perform treatments with known side effects if there is no solid study proving the mechanism and benefits of that intervention" is unreasonably strict. Proning (laying the patient on their stomach appears to improve oxygenation and improve outcomes) was suspected to be helpful by May of 2020. However, even by December of 2020 there were not any large randomized controlled trials proving this. Proning has risks (like "unplanned extubation" i.e. the breathing tube coming out when it shouldn't). Should we have foregone that treatment because there was no proof of either efficacy or mechanism, and there were significant risks associated with the treatment? I personally don't think ivermectin is terribly likely to be effective, but the more general statement of "nobody who is capable of reasoning about science would be a proponent of an unproven treatment that has risks" is wrong.
    - acdha 5y ago
      That's exactly the kind of reason why I included “no known method”: proning was not a previously unknown concept, it clearly changes a known problem, and the risks are manageable. Remdesivir and other antivirals were similarly reasonable to try since they had a plausible method of being effective, as did the steroid treatments which have been so useful for controlling inflammation. Now, nobody is saying that we can't _try_ new things but note also that I was referring to “proponents” — not just people who are willing to try something but who are actively advocating it as an effective treatment. The vast, vast majority of those people are not running experiments or even medical professionals who might possibly have some relevant prior experience suggesting it was worth trying. I'm not opposed to research but I think there's a substantial ethical line to cross when you switch from being open to the possibility of something working to running around telling everyone that it works so well they should avoid a safe, cheap, and highly effective vaccine.
- gonational 5y ago
  The United States CDC literally changed the definition of "vaccine" this year, so that these products could still be identified as vaccines. You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed, but instead only expressed to create the therapeutic effect. But it is "scientifically literate" to call such a therapy a "vaccine"? I hope more common sense literate proponents of science can appreciate how much it harms their case for a vast majority of science advocates to be loud and wrong.
  - mikeyouse 5y ago
    > You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed .. Yes. That's exactly what I'm saying. Read your sentence back to yourself. > But it is "scientifically literate" to call such a therapy a "vaccine"? Yes. Of course it is. Regardless of what the copy on some obscure CDC website says, mRNA vaccines have been in development for decades.
    - gonational 5y ago
      > Regardless of what the copy on some obscure CDC website says Read that, out loud... All you need to do is set your search parameters to filter out items from the past 24 months. https://www.nature.com/gt/journal-information https://www.nature.com/gt/journal-information https://www.nature.com/scitable/topicpage/gene-based-therapeutic-approaches-3881/ https://www.nature.com/scitable/topicpage/gene-based-therape... There are thousands more. SMH... short memory span is the worst part of the human condition.
  - jrmg 5y ago
    > The United States CDC literally changed the definition of "vaccine" this year, so that these products could still be identified as vaccines. For anyone else curious: Before the change, the definition for “vaccination” read, “the act of introducing a vaccine into the body to produce immunity to a specific disease.” Now, the word “immunity” has been switched to “protection.” [1] It seems obvious to me that this was changed because the layperson’s interpretation of the old wording would make it seem like 100% immunity was the result of vaccination. That’s never been the case. The new wording is just clearer in regular English. > You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed, but instead only expressed to create the therapeutic effect. It’s not only science illiterate, it’s misleading to a layperson too. It sounds as if it’s changing the patient’s DNA. > I hope more common sense literate proponents of science can appreciate how much it harms their case for a vast majority of science advocates to be loud and wrong I do t understand how you think your interpretations lie closer to “common sense”. They seem to me to be more like;y to mislead. [1]https://www.miamiherald.com/news/coronavirus/article254111268.html#storylink=cpy https://www.miamiherald.com/news/coronavirus/article25411126...
- walterbell 5y ago
  Non-sterilizing mRNA vaccines are biologics, which have separate regulations and distinct intellectual property protections in national laws and international trade treaties.
dionian 5y ago
Well, there are certainly no long-term studies.
gonational 5y ago
Would you mind linking me to the evidence that this is incorrect? Posts like mine are being censored across-the-board on the Internet because of "interests". I mean, how much more evidence could you possibly linked to then 119 studies, yet my comment was flagged out of existence. We are literally living in a George Orwell novel and the people with jackboots are just ordinary citizens, putting the boots on their own necks. We are under the spell of like a self-prescribed global brainwashing campaign. Nobody cares about science anymore, nobody cares about the scientific method, nobody cares about actual data anymore, only propaganda. 119 studies show evidence of one thing. That's not enough though. But then the media says another thing and everybody believes it, despite the fact that there are dozens of studies with conflicting data showing various counter arguments (such as the Israeli pre-print from three weeks ago showing that The gene therapy is less effective than natural immunity by a factor of 13 to 27 times). This was practically completely ignored by the media and everybody on this site. In the past everybody here would've been on that shit immediately, trying to figure out if it was correct, I mean don't we want out of this mess? Does anybody want out of this or does everybody feel good about having a boot on their neck for the rest of their lives? Let go of your ego for a minute and ask yourself that question for real. If you're one of the people who will down vote this comment, there is no help for you in the long run. But if you want to be honest with yourself, and you want this bullshit situation to end, then you need to look at the real science in the real data and ask real questions and be open to the answers. Even if it means you made a terrible mistake somewhere along the way.
- creddit 5y ago
  I vouched for your comment. You're allowed to believe whatever irrational things you'd like and comment about them as much as you'd like as far as I'm concerned. Seems it got flagged to death even after the vouch, though. Let's, however, consider your inane views on the RNA vaccines (note that not only is this what everyone refers to them as, it's also the case that they are very specifically NOT therapies as they are meant to be prophylactic to disease rather than treat disease). > such as the Israeli pre-print from three weeks ago showing that The gene therapy is less effective than natural immunity by a factor of 13 to 27 times) Do you really have no idea why that's a stupid attack on the vaccines? The idea that natural immunity is superior to vaccine acquired immunity says NOTHING about whether or not a vaccine provides immunity. If A > B, that doesn't mean that B = 0. Not only that, but the same study showed that natural immunity + vaccine > natural immunity. So by your inane logic, natural immunity alone does nothing! But even with this study by all accounts being valid, what policy decisions would you change based on it? It's not like we would stop vaccinations! What's more you're concerned that people are ignoring these 119 studies but you yourself claimed there was literally no evidence of effect for the vaccines when there are hundreds of studies (including your cited Israeli study for God's sake!) showing their effectiveness! Beyond all of that, I know of 1 good RCT for Ivermectin in the Together Trial (1500 patients unlike the comedy of many of the studies you quote) and uh, no effect. Weirdly, they do find really great effect from Fluvoxamine and yet you quacks never decided to pursue that for some reason...
godzulu 5y ago
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm https://www.sec.gov/Archives/edgar/data/1682852/000168285220... Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
NaturalPhallacy 5y ago
No it isn't. Long term studies of them are not possible without time travel.

mikeyouse 5y ago

Calling them gene therapies too.. wow. I hope the more science-literate proponents of IVM can appreciate how much it harms their case for the vast majority of IVM advocates to be this loud and wrong..

acdha 5y ago
> I hope the more science-literate proponents of IVM If they valued and were capable of reasoning about the science, they would not be “proponents” — they'd recognize the current scientific understanding (no known mechanism or benefits, significant side-effects) and wait for a solid study before recommending anything. The people you do see advocating it are almost always doing so for political or financial purposes and are thus unlikely to say anything critical since that'd be bad for business.
- creddit 5y ago
  Ivermectin doesn’t really have significant side effects at appropriate doses. It’s quite safe. Don’t be fooled by overblown “horse dewormer stories”. I don’t say this to advocate Ivermectin, the only RCT I know of/trust found absolutely no effect. I say this to gently point out the mismatch between your claims and the premise in the first sentence.
  - fullstop 5y ago
    I agree that it is safe at appropriate doses. The issue is that people are self medicating and incorrectly calculating doses, since the product was intended for livestock.
    - gonational 5y ago
      The nationwide report that everybody talked about, pertaining to poison control centers receiving endless calls about this was completely fake. It turned out that rather than 70% of calls it was actually 2% of calls and over half of them were simply people asking questions about dosage. The other nationwide report about the hospitals in Oklahoma being crowded with ivermectin victims to the point where they could not even get gunshot victims in to see a doctor... well, at least one of the hospital systems responded with an open letter stating that this was completely fake and that they had not seen even a single patient. I find it hard to believe that one hospital system would not see a single patient while all the other hospitals in the state would be completely flooded with them. If the TV tells you something, you do not have to believe it. Use your brain.
      - fullstop 5y ago
        I never said a word about any of that. I said that people are self medicating and incorrectly calculating an appropriate dosage, and I am not wrong. [1] 1. https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 https://www.fda.gov/consumers/consumer-updates/why-you-shoul...
        gonational 5y ago
        What evidence did you have that people were doing this, which presumably affected your opinion on this topic?
        fullstop 5y ago
        1. Facebook groups where people have admitted to taking more than they should have, causing incontinence. Not public groups, but one local to my area. 2. The FDA themselves I have to ask, are you actually advocating for self-medicating with products from Tractor Supply? I've not once said anything about my opinion of Ivermectin, only that of self medication.
        5y ago
  - marcosdumay 5y ago
    Still, I don't think anybody talking about using ivermectin for treating COVID-19 ever recommended what is widely tested appropriate doses.
- gonational 5y ago
  Yeah, because nothing says "recognize the current scientific understanding" like dismissing hundreds of studies because of a couple bunk meta-analysis. Also, nothing says "recognize the current scientific understanding" like injecting an untested medicine into your veins to avoid what amounts to the common cold for younger people; while ignoring the fact that it does not help prevent the spread, and according to the latest study on this from Israel (the highest vaccine rate in the world), actually enhances the spread, so if the argument is "what about the old people that you're going to infect", then I guess you've answered that question already. It pays nothing to pretend that you are smarter than other people if you're not willing to follow your own advice.
  - acdha 5y ago
    You're packing enough untrue things into that comment that it's hard to believe you're acting in good faith but: * It's dismissing the studies which show effects due to errors, which leaves the studies not showing beneficial effects. Science is built on evidence and thus far it hasn't been shown that Ivermectin has a benefit for COVID. * Similarly, it's untrue to the point of being a flagrant lie to claim that the vaccines are untested when they went through full clinical trials and the high positive effects and safety rates shown in those trials have been backed up by data from many millions of people * Similarly, it's flat out wrong to claim that COVID is similar to the common cold — even if you compare it to influenza, which is far more serious, that's not true — we've seen more children die in the last couple months than we typically see in an entire flu season. * Vaccination does help reduce the spread, and that's even shown in the Israeli data — it's not 100% but if you look at the data it's very clear that vaccinated people at a significantly lower rate. Israeli comparisons are tricky because they have substantially different vaccination rates across age categories and a vaccinated 80 year old is still more at risk than someone younger, especially when those younger people are not taking precautions, which brings me to: * Israel is nowhere near having the highest vaccine rate — that's a tie between Portugal, Malta, and the U.A.E. currently — and at a paltry 62% they're not even in the top 25. That's only slightly better than the United States at 55%. * The Iraeli data does not show that vaccination increases spread: this is a lie spread by people who are comparing unlike things in the knowledge that many people will reshare those claims without checking them.
- JoshuaDavid 5y ago
  > If they valued and were capable of reasoning about the science, they would not be “proponents” — they'd recognize the current scientific understanding (no known mechanism or benefits, significant side-effects) and wait for a solid study before recommending anything. The the standard of "we should not perform treatments with known side effects if there is no solid study proving the mechanism and benefits of that intervention" is unreasonably strict. Proning (laying the patient on their stomach appears to improve oxygenation and improve outcomes) was suspected to be helpful by May of 2020. However, even by December of 2020 there were not any large randomized controlled trials proving this. Proning has risks (like "unplanned extubation" i.e. the breathing tube coming out when it shouldn't). Should we have foregone that treatment because there was no proof of either efficacy or mechanism, and there were significant risks associated with the treatment? I personally don't think ivermectin is terribly likely to be effective, but the more general statement of "nobody who is capable of reasoning about science would be a proponent of an unproven treatment that has risks" is wrong.
  - acdha 5y ago
    That's exactly the kind of reason why I included “no known method”: proning was not a previously unknown concept, it clearly changes a known problem, and the risks are manageable. Remdesivir and other antivirals were similarly reasonable to try since they had a plausible method of being effective, as did the steroid treatments which have been so useful for controlling inflammation. Now, nobody is saying that we can't _try_ new things but note also that I was referring to “proponents” — not just people who are willing to try something but who are actively advocating it as an effective treatment. The vast, vast majority of those people are not running experiments or even medical professionals who might possibly have some relevant prior experience suggesting it was worth trying. I'm not opposed to research but I think there's a substantial ethical line to cross when you switch from being open to the possibility of something working to running around telling everyone that it works so well they should avoid a safe, cheap, and highly effective vaccine.
gonational 5y ago
The United States CDC literally changed the definition of "vaccine" this year, so that these products could still be identified as vaccines. You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed, but instead only expressed to create the therapeutic effect. But it is "scientifically literate" to call such a therapy a "vaccine"? I hope more common sense literate proponents of science can appreciate how much it harms their case for a vast majority of science advocates to be loud and wrong.
- mikeyouse 5y ago
  > You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed .. Yes. That's exactly what I'm saying. Read your sentence back to yourself. > But it is "scientifically literate" to call such a therapy a "vaccine"? Yes. Of course it is. Regardless of what the copy on some obscure CDC website says, mRNA vaccines have been in development for decades.
  - gonational 5y ago
    > Regardless of what the copy on some obscure CDC website says Read that, out loud... All you need to do is set your search parameters to filter out items from the past 24 months. https://www.nature.com/gt/journal-information https://www.nature.com/gt/journal-information https://www.nature.com/scitable/topicpage/gene-based-therapeutic-approaches-3881/ https://www.nature.com/scitable/topicpage/gene-based-therape... There are thousands more. SMH... short memory span is the worst part of the human condition.
- jrmg 5y ago
  > The United States CDC literally changed the definition of "vaccine" this year, so that these products could still be identified as vaccines. For anyone else curious: Before the change, the definition for “vaccination” read, “the act of introducing a vaccine into the body to produce immunity to a specific disease.” Now, the word “immunity” has been switched to “protection.” [1] It seems obvious to me that this was changed because the layperson’s interpretation of the old wording would make it seem like 100% immunity was the result of vaccination. That’s never been the case. The new wording is just clearer in regular English. > You're going to tell me that it's "science illiterate" to consider mRNA therapy as gene therapy, because the genes are not actually changed, but instead only expressed to create the therapeutic effect. It’s not only science illiterate, it’s misleading to a layperson too. It sounds as if it’s changing the patient’s DNA. > I hope more common sense literate proponents of science can appreciate how much it harms their case for a vast majority of science advocates to be loud and wrong I do t understand how you think your interpretations lie closer to “common sense”. They seem to me to be more like;y to mislead. [1]https://www.miamiherald.com/news/coronavirus/article254111268.html#storylink=cpy https://www.miamiherald.com/news/coronavirus/article25411126...
walterbell 5y ago
Non-sterilizing mRNA vaccines are biologics, which have separate regulations and distinct intellectual property protections in national laws and international trade treaties.

dionian 5y ago

Well, there are certainly no long-term studies.

gonational 5y ago

Would you mind linking me to the evidence that this is incorrect? Posts like mine are being censored across-the-board on the Internet because of "interests". I mean, how much more evidence could you possibly linked to then 119 studies, yet my comment was flagged out of existence. We are literally living in a George Orwell novel and the people with jackboots are just ordinary citizens, putting the boots on their own necks. We are under the spell of like a self-prescribed global brainwashing campaign. Nobody cares about science anymore, nobody cares about the scientific method, nobody cares about actual data anymore, only propaganda. 119 studies show evidence of one thing. That's not enough though. But then the media says another thing and everybody believes it, despite the fact that there are dozens of studies with conflicting data showing various counter arguments (such as the Israeli pre-print from three weeks ago showing that The gene therapy is less effective than natural immunity by a factor of 13 to 27 times). This was practically completely ignored by the media and everybody on this site. In the past everybody here would've been on that shit immediately, trying to figure out if it was correct, I mean don't we want out of this mess? Does anybody want out of this or does everybody feel good about having a boot on their neck for the rest of their lives? Let go of your ego for a minute and ask yourself that question for real. If you're one of the people who will down vote this comment, there is no help for you in the long run. But if you want to be honest with yourself, and you want this bullshit situation to end, then you need to look at the real science in the real data and ask real questions and be open to the answers. Even if it means you made a terrible mistake somewhere along the way.

creddit 5y ago
I vouched for your comment. You're allowed to believe whatever irrational things you'd like and comment about them as much as you'd like as far as I'm concerned. Seems it got flagged to death even after the vouch, though. Let's, however, consider your inane views on the RNA vaccines (note that not only is this what everyone refers to them as, it's also the case that they are very specifically NOT therapies as they are meant to be prophylactic to disease rather than treat disease). > such as the Israeli pre-print from three weeks ago showing that The gene therapy is less effective than natural immunity by a factor of 13 to 27 times) Do you really have no idea why that's a stupid attack on the vaccines? The idea that natural immunity is superior to vaccine acquired immunity says NOTHING about whether or not a vaccine provides immunity. If A > B, that doesn't mean that B = 0. Not only that, but the same study showed that natural immunity + vaccine > natural immunity. So by your inane logic, natural immunity alone does nothing! But even with this study by all accounts being valid, what policy decisions would you change based on it? It's not like we would stop vaccinations! What's more you're concerned that people are ignoring these 119 studies but you yourself claimed there was literally no evidence of effect for the vaccines when there are hundreds of studies (including your cited Israeli study for God's sake!) showing their effectiveness! Beyond all of that, I know of 1 good RCT for Ivermectin in the Together Trial (1500 patients unlike the comedy of many of the studies you quote) and uh, no effect. Weirdly, they do find really great effect from Fluvoxamine and yet you quacks never decided to pursue that for some reason...

godzulu 5y ago

https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm https://www.sec.gov/Archives/edgar/data/1682852/000168285220... Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.

NaturalPhallacy 5y ago

No it isn't. Long term studies of them are not possible without time travel.