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flipper44

02/23/23 1:15 PM

#570396 RE: DrHigh #570394

Hard to say. They should be ready to submit the MAA by now, JMHO.
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biosectinvestor

02/23/23 4:31 PM

#570477 RE: DrHigh #570394

Nonsense. Doubtful that the mavens on social media know more than they or their top counsel know. They are in direct contact with all of their regulators. More likely they are playing their cards close to their chests and there is more involved in their description than people here realize because here we are all deriving information not directly from the sources but deductively… as in blind men feeling an elephant and trying to determine what it is…

They are in the middle of it, NICE is reviewing things long before what would be typical, which would be after approval. What does that tell me, deductively. Well that only happens when you’re on the ILAP track. ILAP also provides for rolling review. In a rolling review what might hold up considering an application complete? Well, having all of the pieces could hold it up, though they would likely be reviewing other details already submitted, but that would not make a complete application. Seems to me that another item likely might be something like the commercial manufacturing licensing process. Just because it is rolling doesn’t mean an application is “complete” or “submitted” for final approval. There are critical pieces rolling in.

That they may not want people to know the full details of what is going on … might be because of some other factors of which we are not informed. One thing that is possible is that a bunch of compelling news might drop all at once.

The reality is that people on social media like to convince each other that they know more and know better. Given the experience and knowledge of LP and their counsel, and various parties involved, including direct access to each regulator, counsel typically call directly to internal regulatory facilitators and similar personnel at the regulatory bodies as needed, it is extremely unlikely that anyone out here on the boards knows more than they do if only because status information out here, if not given directly by the executives or a regulator agency, is derived through deduction and is error prone. It can be slightly enlightening, and of course we all strive for more understanding by deducing anything we can from what we know. But the process of such analysis is flawed and vulnerable to false notions of superior knowledge and even superiority.
Bullish
Bullish