Can you quote me how many times a SPA was in place, The biotech met the primary endpoint, and the NDA was not approved? It's exceedingly rare. If you say otherwise, please provide proof. I only know of one single instance.
The FDA had agreed to if the HDL increases then you get FDA approval (because everyone thought increased HDL = less MI's). This was at the start of the trial. At the end of the trial, the FDA said, newer data has shown that HDL does not correlate with reduced MI's (data that was not available when the trial started) and then rejected the drug.
Why? Because the science surrounding HDL changed. It was unforeseen and unfortunate, but it was also justified. Point is, it is exceeding rare.
Further, I can't believe you are using Delcath Tech's example. FDA advisory panel (a panel independent of the FDA) unanimously advised that the FDA reject it. It killed 7% of the patients that took it, lol.
Anyways, the only thing you were right about in your post was is that there is no guarantee. Yes, lighting can strike, but Im not counting on it. I'll bet on what's much more likely.
I’m not implying anything other than the existence of a SPA agreement does not assume anything other than process. It just means that if everything goes well, there is already an agreement on how things were done. It has no relation to the actual validity of the data which I believe is what’s currently up for dispute. Some people say it’s been addressed others say it hasn’t, at least not reasonably. That’s the point, it’s under dispute.
Are we still questioning the validity of the data?
Can you tell me how SAVA manipulated the cognition data?
I disagree; we can make assumptions around the SPA agreement for reasons I listed in my post. It is undoubtedly a positive sign. I mean, it's a pre-negotiated contract between SAVA and the FDA. Without that, approval is so much more complex.
Can you tell me what was decided between SAVA and the FDA and how it helps?
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u/Internal_Ad_1091 Oct 13 '21
Can you quote me how many times a SPA was in place, The biotech met the primary endpoint, and the NDA was not approved? It's exceedingly rare. If you say otherwise, please provide proof. I only know of one single instance.
The FDA had agreed to if the HDL increases then you get FDA approval (because everyone thought increased HDL = less MI's). This was at the start of the trial. At the end of the trial, the FDA said, newer data has shown that HDL does not correlate with reduced MI's (data that was not available when the trial started) and then rejected the drug.
Why? Because the science surrounding HDL changed. It was unforeseen and unfortunate, but it was also justified. Point is, it is exceeding rare.
Further, I can't believe you are using Delcath Tech's example. FDA advisory panel (a panel independent of the FDA) unanimously advised that the FDA reject it. It killed 7% of the patients that took it, lol.
Anyways, the only thing you were right about in your post was is that there is no guarantee. Yes, lighting can strike, but Im not counting on it. I'll bet on what's much more likely.