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FeMike

10/20/22 3:05 PM

#523554 RE: skitahoe #523546

When they make a submission they don't announce it, if it's accepted, then they announce it. If the regulator doesn't accept it, they'll provide guidance on what needs to be changed, they make the change, resubmit, and wait to see if the get an acceptance. Again, they only announce the acceptance.



Well this is just patently false.

Companies very regularly, I’d say more often than not, announce submissions of BLA’s/MAA’s.
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HappyLibrarian

10/20/22 3:17 PM

#523569 RE: skitahoe #523546

I don't know how many times things need to be said, going back to when L.G. appeared on the show they've been saying that they're advancing toward approvals



Mr. Goldman seemed 'upbeat' on the Big Booze show 2 years ago, just like he was 5 years ago when shareholders would call him up. He might have said advancing towards approvals but it's been more like crawling towards approval.

The reason things need to be said over and over is that the 'they are following the plan set forth on October 5, 2020' loses its power, repetition notwithstanding when they make a clear (to an objective, outside observer) departure from that plan by orchestrating the release of TLD by a 3rd party on May 10th 2022 and more to the point, 2 years have passed with no clear time frame for the current quiet period and process to end.