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Investor2014

04/11/20 5:59 PM

#245926 RE: F1ash #245921

That would almost certainly invoke the curious Benjamin Button effect.
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georgejjl

04/11/20 6:10 PM

#245929 RE: F1ash #245921

Your statement is not necessarily true:

If bioavailability is improved due to reformulation then 50 mg would probably be well beyond MTD imho



If the new formulation with increase bioavailability is an oral extended release formulation which can give the better efficacy with little to no side effects by keeping the therapeutic dose at a steady level in the body for longer periods of time.

GOD bless,
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jimmy667

04/11/20 6:17 PM

#245930 RE: F1ash #245921

This is the easiest puzzle to solve.
The words "You will receive" Means that all of the trial participants will be given the high dose of 50 mg of MTD in the open label extension study. In the first blinded part of the study some would be on other doses or placebo. So this could not possibly pertain to the blinded study. Plus could not change dose in blinded study....because...well its blinded.
This does however support my earlier thesis that the blinded part would use low, medium and placebo. Then calculate the statistically valid signal without the risk of AE derailment. In the OLE use 50 mg high dose or MTD of each patient.
In other words void the null hypotheses in the blinded trial by showing effect beyond placebo then continue to OLE at MT dose for each patient to show full efficacy vs. SOC.