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Alias Born 07/12/2002

GD

Re: fluteman post# 36983

Saturday, 04/17/2021 5:31:54 PM

Saturday, April 17, 2021 5:31:54 PM

Post# of 43747
The simple and logic way to think is small biotech companies want
to share good PIII data as soon as possible for many reasons, to
raise money for FDA submission, prepare CMC, patent life clock...
and once data base is locked, the trial's fate is sealed, the
primary endpoint and secondary endpoints and all other data
can be searched by spreadsheet software, the tables, graphs, HR
and P values are easy to produce from numbers in data base and does
not take months, IMO. To FDA and street, if the primary endpoint
misses the P value, more than 0.05, the PIII trial is technically
failed, it does not mean FDA will 100% not approve the drug, but
company has to fight for the approval and street may not give much
value to the drug until after approval, IMO.
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