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Re: DrHigh post# 600755

Monday, 06/12/2023 4:46:50 PM

Monday, June 12, 2023 4:46:50 PM

Post# of 705436
Agreed. As I said, they will shout from the rooftop whenever the application is accepted. And our clock will start from that point on. In case of FDA, we will be assigned a PDUFA date about 6 months out once the BLA is accepted.

No reason not to PR that. Shorts and manipulators can do nothing at that stage in terms of influencing the decision making process of the regulators. So all this crap about keeping it hidden from shorts because they can influence regulators and what not is BS.

I continue to believe there will be no application submissions this summer and the narrative will shift to SNO in mid November. Why didn’t Dr. Bosch accept Q&A at ASCO? He didn’t want to respond to difficult question(s) around RAs because it’s entirely possible they are not that close to submitting yet. At least that’s the impression you get from the defensive positioning. If the application was already submitted or they were really close to submission, you’d want to invite such questions and respond positively (while staying within the boundaries of the regulators).
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