Cycl2R, My question is: did he actually submit
Post# of 148293
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Posted On: 04/20/2020 8:59:52 AM
Cycl2R,
CYDY had prepared a submission with 525mg dose and was working on the asumption that this was going to be what the BLA application will contain; however very successful results in the Mono trial with 700mg induced the FDA to request the "whole enchilada", that is, all the current data from Mono AND the stability for 700 mg as well (which we did not have finalized).
Eventually FDA put us on hold as they decided on what they wanted and only recently they communicated their choice.
Which delayed us considerably, of course.
What I was trying to convey is that FDA knows very well parts of the application as they have been involved on what to apply for. Those studying and hopefully, approving the clinical part already know it inside-out (mostly the statistics & effectiveness of different doses which undoubtedly studied before advising us what to apply for).
Quote:
My question is: did he actually submit these clinical parts to the FDA?
CYDY had prepared a submission with 525mg dose and was working on the asumption that this was going to be what the BLA application will contain; however very successful results in the Mono trial with 700mg induced the FDA to request the "whole enchilada", that is, all the current data from Mono AND the stability for 700 mg as well (which we did not have finalized).
Eventually FDA put us on hold as they decided on what they wanted and only recently they communicated their choice.
Which delayed us considerably, of course.
What I was trying to convey is that FDA knows very well parts of the application as they have been involved on what to apply for. Those studying and hopefully, approving the clinical part already know it inside-out (mostly the statistics & effectiveness of different doses which undoubtedly studied before advising us what to apply for).
(2)
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