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Re: flipper44 post# 668314

Monday, 01/29/2024 11:10:15 AM

Monday, January 29, 2024 11:10:15 AM

Post# of 708461

,January 2, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:

Over the next three months, the Company will be preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information. Our clients are heavily involved with that process every step of the way. I will be happy to provide more detail on what that process will entail during today’s call.”

If the MHRA review process mirrors thr FDA process, the manufacturing inspection is usually one of the last things crossed off on the approval checklist before approval. Looks like the review is on an expediated timeline. And coinciding w the CHM meeting on March 21-22. Could it be they'll have all the ducks lined up in a row by then? I'm not going to say what I think.😁
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