What happens to our BLA and approval for HIV if FDA approves the Gilesd capcid drug first? Will we still have the same chance at approval based on our corrected BLA?
If we are now competing against Gilead’s capcid inhibitor, how did that drug perform in its phase 3 trials compared to LL?
Finally this person tweets that 2/3 of blood samples from our trials were not saved, hence we cannot do the ROT now? Is this true and how then might Dr. Recknor fix this? Somebody can mail him and ask on this.
Yes, I recently learned this as well. The main issue is that a previous lab, before InCellDx, did not save blood on 2/3 of cases. You can’t do ROT! Rather you need a scientist such as Dr Patterson to work w FDA on alternate options for HIV BLA approval. @brucep13
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