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CytoDyn Inc CYDY
(Total Views: 259)
Posted On: 05/02/2019 9:47:42 AM
Post# of 154133
Posted By: gestalt2
Re: sjacobs26 #2371
I don't want to predict hugely optimistic outcomes for the TNBC, But I think you are right that the FDA might move this much quicker than we think. This is why the safety data is so important - If the FDA sees that various doses have no side effects then taking the risk to approve at a very early stage is so much easier for them. The 700mg safety data is not about the combo BLA as much as it is for all future indications. It is one thing to get the first BLA filed complete, but if we get a surprise gift from the FDA for the TNBC, then the industry will have to realize this can get into patients much sooner than any timeline will indicate.













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