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La Flaca

10/02/25 3:19 PM

#502024 RE: Bourbon_on_my_cornflakes #502021

Is this for AVXL?
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Hoskuld

10/02/25 3:41 PM

#502030 RE: Bourbon_on_my_cornflakes #502021

Usually there is a data safety monitoring board that reviews data periodically to ensure that SAEs are not arising of a size and frequency that would call for the trial to be shut down - or in the case of a serious indication, the DSMB could be looking for a total absence of efficacy or even a general worsening that would justify the same thing. Occasionally, the DSMB sees incredible efficacy and recommends stopping the trial because it would be unethical not to offer it to the placebo patients too. This latter case happens very, very rarely - like in the case of 100% fatal childhood leukemia where there is 100% efficacy of the therapy.

Is your DMC - DSMB?
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LakeshoreLeo1953

10/03/25 10:33 AM

#502070 RE: Bourbon_on_my_cornflakes #502021

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-data-monitoring-committees-clinical-trials

ZIG...Nothing in yesterdays price action would come close to
describing supply being added to the float.
A credible concern for the future, but yesterday?
Almost certainly an over reaction to the PR.
IF the burn rate is to be believed, the only reason for immediate "dilution"
would be a less than successful EMA decision.
As all with open minds should anticipate that does NOT mean full blown approval.

Perhaps in answer to post decision SP range,,,
Down side is likely 50%.
Upside harder to anticipate as I BELIEVE there are different levels of approval.
My guess however with a restricted label or contingent further trial is a double or slightly more.
All bets are off upside if the WGT assurances become reality.....which I doubt.

In the meantime, I need $10 to be even.