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Re: BioHedge post# 83687

Monday, 12/22/2014 11:30:33 AM

Monday, December 22, 2014 11:30:33 AM

Post# of 402812
Good morning BH, glad to see you on.

So my view of the PR, maybe you can help me... It seems as though the FDA was looking for more detail in the PK, "Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained"pharmacokinetic (PK) data.

Sounds more like the FDA is saying it would benefit Cellceutix to hold on and get more of this data in a "results" format, possibly to improve the chances for aquiring benefits of QIDP(which are still not a given). Maybe there is more benefit to what B actually produced in the Phase 2b than we are privy to.

I just haven't seen any good conversation about the actual content to the PR this morning and was hoping for someone with a bit more understanding of the bio side of things, seems ther is some verbage in there abour mrsa and stuff that may shed light for someone that knows.

GLTA
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