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Re: GM_FSJ post# 4601

Wednesday, 10/08/2014 5:14:36 PM

Wednesday, October 08, 2014 5:14:36 PM

Post# of 118384
Indeed, I was thinking what we might see is either Orphan approval or FDA approval in about two weeks. This will be followed up with the eventual response from the FDA regarding dCellVax.

One question I do have is, given that the pre-clinical trials were submitted to the FDA with the IND, would we get approval to proceed with clinical trials? In other words, are we just waiting for an IND number or an IND number and FDA approval to proceed with clinical trials for dCellVax?

The opinions, comments, or concerns, expressed herein, are solely that of 'd5wr59mfi8'; they're not to be misconstrued as any form of advice and any suggestions should not be followed.