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biosectinvestor

04/12/23 9:17 PM

#584811 RE: branster #584806

Thanks Branster. I appreciate your asking and my remarks were to the substance not in any way toward you. I think Flipper made it seem that way.

The reality is they did not PR the Pip on Submission. DI is incorrect from the start of his answer. They PR’d the approval. They did PR the application for Commercial Manufacturing, but the process does not entail the same confirmation that the application is complete or requests for more information which can further delay final submission for at least another month or so, or for a longer period of time.

Honestly, I think that was a flippant answer, and not thoughtful. I do not think DI is a regulatory guy and I do not think he will likely be making that decision. Think he just shot back an answer. That’s my honest opinion. I think it would be stupid of them to PR submission without knowing their submission is complete and accepted. It is only 30 days later, as I recall, and if it is not complete it could be a month or months later and causes them to have to reveal the delay, etc. It would be silly for them to put themselves in that position.

The only people an earlier notice benefits are swing traders who are jumping in and out. They might even get a few trades out of it. But it doesn’t give a certain answer to longs that the time line for approval has been engaged. Only acceptance triggers that review timeline.