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Re: trding post# 12160

Monday, 03/13/2017 10:10:37 AM

Monday, March 13, 2017 10:10:37 AM

Post# of 233768
I remember the conf. call when the announcement for the denial of BTD last time. It was because they were using the data from p2b trials which are mono trials and the BTD was for adjunct use. It was stated that the data needed was only i think 5 patients, and we have at least 7 that we are certain of in adjunct p3, i would think that is why the re-application for BTD was done. It would be very surprising if the FDA did not give BTD this time. I also remember that Nader did not think BTD was that important because they were already getting preferential treatment from the FDA to a degree equivalent to having BTD. all the more reason to beleive the FDA wants cytodyn to apply and get BTD just to justify the preferential treatment they are getting.
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