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Doktornolittle

08/08/14 3:36 PM

#16805 RE: Pyrrhonian #16803

Pyrrhonian: If you are right, what would the constraints be for their announcing the application for AA? Would the application have to be formally accepted first?

There were some that thought that enrollment would have to be complete before announcing such. You weren't one of the people that thought that to my recollection.

Any other possible reasons they would keep it a secret?; other than interference with trial enrollment due to implied efficacy making patients less wanting to risk getting a placebo?

foxhound02

08/08/14 5:40 PM

#16813 RE: Pyrrhonian #16803

Are you suggesting that a BLA is being filed without the company knowing the results??????????

"The two big clues imo are the interim efficacy data recommendation not being delivered to the Sponsor and the sample size increase, indicative of lower event rates. To me that spells a BLA is currently being filed for AA. And so this increase of events required to conclude the trial may not matter, as the trial concludes once AA is granted."