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now I think I know what it means,

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Fosco1 Member Level  Friday, 10/30/20 11:26:46 AM
Re: timberwolf7 post# 2472
Post # of 2551 
now I think I know what it means, quite precisely now. You can check with IR if you wish,

The drug is good, I have little doubts about it, as shown in PII and also in Test arm in Ph III
The problem is the design. The design makes that many patients in the control arm can't be elligible, because they fail engraftment or so. So they are left with very few patients in Standard of Care to compare TEST arm too. If you look at what they say, there is probably around 45 patients in Test arm and 7 elligible in control in this 75% interim. That's too few for significance comparing, for a p value below 0.05.

The way out for them in this Ph III is to talk to FDA and ask for historical control rather than a placebo arm ... or re-design the trial ... I am not expert.... from my experience it can take a bit of time to change SAP and primary outcome measures so that you do not compare to a control arm.

This can work out, and I believe drug is good enough for it and can show sufficient benefits.

However, this will take time in my opinion, in the meantime, in best case, Ph III will be stuck in time and cash will burn, in worse they will pronounce futility... so may be come back later would be a good option

Sorry for my final rather negative conclusion on this Ph III Iomab trial, but the wording in 10Q made things hard to read. Let's see now what happens in Q4 regarding this trial.

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