I too question the timing and really wonder what t
Post# of 153903
(Total Views: 584)
Posted On: 08/07/2020 9:44:22 AM
Re: reallypeople? #47701
I too question the timing and really wonder what they are up to. Let the results next week (if we get them) speak for themselves instead of playing games with the FDA. This could easily be interpreted as grasping for anyone who will approve us if we don't have enough data to convince the FDA, and I'm very skeptical of the CD10 and the limited number of patients being able to get to approval as opposed to a P3 trial.
Even more suspicious is our intent to submit on HIV combo. Weren't we supposed to have a meeting this week with the FDA about our BLA that was not accepted? We hear nothing from that and now we're preparing to submit in the UK? How about we get a proper BLA to the US FDA, and then global approvals will be a given.
Even more suspicious is our intent to submit on HIV combo. Weren't we supposed to have a meeting this week with the FDA about our BLA that was not accepted? We hear nothing from that and now we're preparing to submit in the UK? How about we get a proper BLA to the US FDA, and then global approvals will be a given.
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