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Re: A deleted message

Friday, 03/19/2021 9:58:25 AM

Friday, March 19, 2021 9:58:25 AM

Post# of 232926
Didn't we learn the lessons of CD10 and CD12? A low number of arms is a high risk to match the necessary p-value. Excellent clinical results do not win against a low p-value. FDA gives a sh.t what helps the sick people, but what satisfies bureaucrats statistics.

So who is now telling us to lower the number of arms? Is FDA manoeuvring us into the next big disaster "excellent results with getting no approval"?

Is it not better to focus and get enough resource to pass finally one trial successful and get a BLA? CD10 and 12 failed due to too low several arms. HIV combo phase 3 was very successful, but management has still not explained what went wrong (I don't believe the story around occupancy test)with BLA. More than 2 years and no end in sight?
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