Here is a concern I have though for the record I DO NOT BELIEVE THIS IS THE CASE
They suspect MHRA will reject or require a confirmatory trial prior to approval. But they are slow playing responding to them to delay this decision because it will in essence become a death blow. Since they have not officially received the bad news, they do not have to 8k anything. In the meantime they are selling discounted Cs to the inner circle who are methodically dumping on to the mkt to pick up instant arbitrage in addition to selling core positions. Since mgmt cannot sell their shares, they are continuing to prop up Advent for a post NWBO life. Retail shareholders get left with nothing
I do not believe this is the case. I think we will eventually get approved but not before LP dilutes us into the stone ages while perhaps setting up another CDMO sale.
Thanks, DD! it really brings some relief. We’re familiar with how the FDA handles rejections, but we’re less certain about MHRA’s typical approach. If MHRA were going to reject the application, it probably wouldn’t be taking this long, right? And in many cases, instead of a direct yes or no, companies end up withdrawing their applications once they realize their chances of approval are low.
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