Re: A non-rose coloured view of the Webcast
in response to
by
posted on
Nov 01, 2019 05:33PM
Sometimes one misses the forest for the trees by being too close to the action...action here being FDA approvals.
The attitude of your contact reflects past received wisdom...that if your Phase 3 did not meet 95% confidence interval...good luck pal, better luck next time. But it is clear from recent FDA action, that they are beginning to appreciate how constrictive that approach has turned out to be. Not only has it made it needlessly expensive/time consuming/bureaucratic to get anything done, it has smoothered the approval of new drugs. And this 95% confidence interval is a perfect example. If we hit 90%, that is at least 1.8 times standard deviation...just not the 2 times standard deviation of 96%...which incidentally is more than the 95% confidence interval. So you can get a sense of the arbitrariness of the 95% figure.
The FDA under and after Scott Gottlieb has taken a more relaxed stance to approving new drugs. The # of drugs approved have soared in the Trump years. Time needed for approval has drastically reduced. Drugs that would not even be considered for approval in the Obama years are being accepted...coz there is "no available medicine for such disease". In other words, dubious drugs have been approved. Did your contact ever mention dubious drugs being approved? Anyway, my point is that the FDA is far more friendly to new drugs today...than in the past.
Contrast that with our drug...uber safe, almost met primary endpoints and with an excellent forest graph coming up. Now you tell me...under what grounds will the FDA say...sorry, you need another 2000 patient years right away? My guess is that the FDA may approve it...but with a provisio of further parallel tests while the whole process of approval goes on. Don McCaffrey can't say this publicly...coz he will accused of talking up his books...plus the FDA does not like to be told what to do...even if it is the obvious thing to do! In summary, I definitely don't think it is a "long shot"...the probability may be far higher than consensus. Full disclosure: I have never spoken to anyone in RVX about this possibility...this is my own conclusion.
So I think your contact may be unable/unwilling to accept that the ground has shifted under his feet.