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Drug trial & FDA questions.... This question is for anyone who had experience working with the FDA and drug-trial environment. Has the FDA ever approved a drug based on a trial that just barely missed meeting its primary end-point, but subsequent review of the trial's data showed that trial's drug dramatically reduced another critical ailment that was not that trails' focus??? Another way to phrase the question is: can *only* that "failed" trial support the approval of a drug that dramatically reduced an ailment within that trial and had NO safety issues? I know the FDA is hugely anal about being careful with approving drugs. I just wonder if the FDA will force another trial to specifically test that ailment even though the initial trial showed that drug did dramatically reduce that ailment, with no safety issues. Background: Novavax recently had a trial for a vaccine that targeted reducing RSV in children for the early months of their lives (when RSV is a HUGE issue). The vaccine failed to meet its primary end-point of 40% reduction, when the data showed a 39% reduction (a very close miss). But, subsequent review of the data showed a 50% reduction of pneumonia related illnesses in the test group. The specifics of that particular data is in the link below. So, I'm just wondering if the FDA would accept this vaccine, that had no safety issues, to combat pneumonia related illness in infants, when the trial's focus was for RSV. Novavax has moved from a low of $4.01 to now being $7.84, after the release of that new data. Other news has also been released about other factors that could also help explain the price increase. If such an FDA-approval precedent has been experienced in the past, this recent increased is nothing compared to what will happen if the FDA accepts the review of the trial's data relative to combat pneumonia. ======================= |
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Msg # | Subject | Author | Recs | Date Posted |
28156 | Re: Drug trial & FDA questions.... | Dreggy | 2 | 8/19/2019 11:07:38 AM |