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Re: A deleted message

Wednesday, 10/26/2022 6:29:31 AM

Wednesday, October 26, 2022 6:29:31 AM

Post# of 703430

The time period a normal functioning biotech would, under the same circumstances, have already submitted a request for approval for DCVAXL has long come to pass.



Just a quick question: Have you ever held a small, pre-commercial biotech through the BLA regulatory process? Or ever held a micro-cap biotech after reporting a successful pivotal, P3 trial? If so, how long was it after the trial ended was the BLA submitted and the drug approved? Just curious if you have any personal experiences with other biotechs in the same boat as NW Bio and compare those time-lines to what has/is happening here.

Therefore one can conclude that NWBO management is deliberately not submitting a request for approval



Did NW Bio telegraph submittal of PIP application in the UK? No, they did not. But this was the first step in MAA approval and was required for commercialization. Management made this move back in Feb. 2022 but only PR'ed the actually approval of the PIP trial design and plan. This would suggest submission of a MAA in the UK will not be PR'ed, only the actually approval of the MAA.
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