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Posted On: 05/17/2021 7:04:55 PM
Post# of 148887
Re: CaptnAmerca #90576
FDA needs a little more.
BTW, whoever posted the Fierce Biotech smear job, here is a letter to the author:
"Thanks for the interesting article about the highly unusual FDA statement. It's interesting to consider FDA's motivation at such an unprecedented statement. I think they are responding to the large public outcry petioning and criticizing them for not giving an EUA to a safe drug that likely is helpful in severe disease.
I just wanted to point out some inaccuracies for the record. FDA states CD10 trial for mild to moderate missed all secondary endpoints. This is false. They hit the 14 day NEWS2 endpoint with statistical significance.
FDA also may have been slightly unfair to them regarding their treatment with respect to the HIV indication. The company asked for approval at one dosage, and the FDA made them submit more data for a different dosage. Unprecedented. Likewise for disallowing 4 doses in the severe/critical trial.
Regarding your article, I believe this statement is false: " Now, the FDA has broken its usual vow of silence on disclosing information on unapproved products to say that CytoDyn’s reshaping of the data is erroneous." FDA doesn't say that in their letter. There is nothing erroneous about prespecified subgroup analysis. What is erroneous about reporting outcomes? They are facts, and facts can not be erroneous.
You further imply that the company lied by reporting on some shady class action lawsuit that will likely never see the light of day: These ambulance chasing lawsuits never do. They are just about always about trying to shake down smaller biotech firms.
You write: "The FDA is not the only one to have noticed CytoDyn’s missteps." If you have evidence that CYDY made misleading claims, it would have been good journalistic practice to present that evidence, instead of continuing to pile on the smear job.
Respectfully,
K"
BTW, whoever posted the Fierce Biotech smear job, here is a letter to the author:
"Thanks for the interesting article about the highly unusual FDA statement. It's interesting to consider FDA's motivation at such an unprecedented statement. I think they are responding to the large public outcry petioning and criticizing them for not giving an EUA to a safe drug that likely is helpful in severe disease.
I just wanted to point out some inaccuracies for the record. FDA states CD10 trial for mild to moderate missed all secondary endpoints. This is false. They hit the 14 day NEWS2 endpoint with statistical significance.
FDA also may have been slightly unfair to them regarding their treatment with respect to the HIV indication. The company asked for approval at one dosage, and the FDA made them submit more data for a different dosage. Unprecedented. Likewise for disallowing 4 doses in the severe/critical trial.
Regarding your article, I believe this statement is false: " Now, the FDA has broken its usual vow of silence on disclosing information on unapproved products to say that CytoDyn’s reshaping of the data is erroneous." FDA doesn't say that in their letter. There is nothing erroneous about prespecified subgroup analysis. What is erroneous about reporting outcomes? They are facts, and facts can not be erroneous.
You further imply that the company lied by reporting on some shady class action lawsuit that will likely never see the light of day: These ambulance chasing lawsuits never do. They are just about always about trying to shake down smaller biotech firms.
You write: "The FDA is not the only one to have noticed CytoDyn’s missteps." If you have evidence that CYDY made misleading claims, it would have been good journalistic practice to present that evidence, instead of continuing to pile on the smear job.
Respectfully,
K"
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