I did not know that the FDA tuesday meeting was be
Post# of 154849
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Posted On: 09/06/2020 11:32:04 PM
I did not know that the FDA tuesday meeting was because the FDA is offering to review the HIV BLA before its submitted. That would be a good reason to hold the tuesday meeting. CYDY can get guidance on the new HIV BLA filing.
I am still struck by the speed with which events have taken place on the HIV BLA.
It seems like it didnt take long for the FDA to respond in writing to CyDY's questions, and then even more quickly to schedule the tuesday meeting only a week after answering CYDY's questions.
I suppose one reason for the FDA's seemingly quick (at least to me but I really dont know) may be that the FDA recognizes that CYDY did not get a fair shake on the timing of their combo HIV program.
HIV seems to me to be moving pretty fast given its previously long drawn out timeframe. But again, I really have no clue what the standard is on these timelines, let alone during covid.
I am still struck by the speed with which events have taken place on the HIV BLA.
It seems like it didnt take long for the FDA to respond in writing to CyDY's questions, and then even more quickly to schedule the tuesday meeting only a week after answering CYDY's questions.
I suppose one reason for the FDA's seemingly quick (at least to me but I really dont know) may be that the FDA recognizes that CYDY did not get a fair shake on the timing of their combo HIV program.
HIV seems to me to be moving pretty fast given its previously long drawn out timeframe. But again, I really have no clue what the standard is on these timelines, let alone during covid.
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