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FeMike

10/05/22 1:39 PM

#519488 RE: StonkMaster #519480

Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.



Except they have been disclosed.

They disclosed that they had not submitted an MAA.

They can't even keep up with their own lies anymore.
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exwannabe

10/05/22 1:40 PM

#519489 RE: StonkMaster #519480

DI:

Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.


What "obvious reasons" DI?

Most companies have no issue disclosing the basic plans for regulatory approval.

Oh, I have never seen anybody bother to disclose a PIP though.
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Horseb4CarT

10/05/22 3:00 PM

#519510 RE: StonkMaster #519480

That’s how your new DI encounter reads to me!

Perhaps the shorts and naked shorts are going to be caught in a tight squeeze after all.
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martyDg

10/05/22 6:04 PM

#519551 RE: StonkMaster #519480

MAA acceptance being PR? If so then that means they still have not submitted it.

or they don’t intend to PR acceptance only the MAA approval which takes months.
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flipper44

10/05/22 6:27 PM

#519566 RE: StonkMaster #519480

Yeah, I’m not certain I come away with the same conclusion. Before when I asked if any MAA acceptance would be promptly reported, he responded, it’s a “milestone”. Which I took as a yes. Now I’m wondering if he is using the singular and plural word “engagement(s)” and the multiple use of word “approval” to say the they are not going to report any regulatory interaction until an “approval” decision is made or denied.

Our engagement(s) with any regulatory body with respect to approvals have not been publicly disclosed for obvious reasons.

We did not speak about the PIP engagement with the MHRA, but we did let everyone know when our protocol for 2 pediatric trials were approved (as an example)


Appreciate your inquiry

DI.

Carrots and sticks.
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Bob_LobLaw

10/05/22 7:47 PM

#519587 RE: StonkMaster #519480

My correspondence with my wife:

I choose not to divulge my communications with Gisele Bundchen given that she is now single again. Should the time arise that we may or may not confirm the nature of our relationship you will be informed

My wife: shut up and bring the garbage cans back in

They have loved dropping little hints that lead to being absolutely nothing. Again the extending their options expiration dates by a few months back in 2020 was a wonderful little game they played. They knew damn well that they were going to repeatedly extend but the shorter term extensions allowed them to “communicate” a message that was a flat out lie w/o ever really saying anything at all
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flipper44

10/06/22 12:49 AM

#519623 RE: StonkMaster #519480

I thought through this DI statement further, and while I now think they’ll wait until an MA determination to announce thumbs up/down, I see the multi-definitional word “engagement” more positively. The PIP analogy he chose was also an engagement, and it ended early and successfully.

Fwiw, I thought it was the most carefully worded email from DI that I’ve seen.
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sentiment_stocks

10/06/22 4:17 PM

#519856 RE: StonkMaster #519480

My thinking is that Dave meant by the word "engagement" that they would not disclose their discussions, interactions, conversations with the RAs. "Engagement" in the sense that he used it can mean the back and forth between the company and the RAs.

As for the PIP, he was likely pointing to it as an example of what they would PR, despite the fact that it may not be officially considered a "material event", because they felt it was "material" to PR it to their shareholders, especially because the same SAP was being used, and the ECAs were to be matched in same manner the P3's ECAs were.

May I suggest that you respond to him and ask if he thinks a MAA should be PR'd upon submission, or upon acceptance, since that issue may have been the question you were looking to get an answer to?