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Re: jesster64 post# 686553

Monday, 04/22/2024 3:45:10 PM

Monday, April 22, 2024 3:45:10 PM

Post# of 698732
By ASCO we'll either have UK approval, or we won't. If we do, I suspect that our booth will get a great deal of attention and likewise if we present in the Expert's Theater, that will be well attended as well. If not, the impact of being there will be much the same as prior years, hard to say what's to be presented in the Expert's Theater, it might concentrate on the EDEN which hasn't received much attention in the past. If by chance Dr. Liau, or anyone else submitted Abstracts on the early phase trials and they're selected for presentation that could be big news.

ASCO comes at the very end of May, the UK decision, if not delayed, should be out by then. Of course we all know the regulators often have delays, so it's not a sure thing, I've given it a 90% probability. I would like to see clarification on the 150 day timeline. Some have said it begins on submission, others on acceptance. We know when the submission was, but people are assuming when it was accepted, nobody but the UK authorities, and perhaps the company know. The difference could mean the difference of a decision before ASCO or a decision essentially right at the time of ASCO if the UK holds to the 150th day, if in fact it's based on acceptance and that didn't occur until sometime in the first, or even second week of 2024. 150 days is essentially 5 months, depending on the acceptance date it could fall during ASCO.

On thing is certain, the UK cannot review even a meaningful fraction of 1.7 million pages in days, weeks, or even a couple months, so no real review was done to accept the filing. That stated, I would think there is still a good chance the submission was accepted nearly immediately, perhaps even before XMAS if the staff there doesn't take the Holiday weeks off. I would suspect that acceptance isn't much more than a time stamp placed on when the entire package was received, which I suspect is electronically, but 1.7 million pages do take some time to transmit.

Gary
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