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It is Really Pretty Simple = They have

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clambottler   Tuesday, 05/26/20 05:35:47 PM
Re: bobshmob post# 80510
Post # of 103570 
It is Really Pretty Simple = They have to Wait and they DO NOT want compassionate use designation.

1. They do not want compassionate use. In a 2 arm placebo trial someone gets the placebo. If all could get drug under compassionate use, no one would risk getting placebo, so no one would volunteer for the trial.

That's how trials work - someone has to get the placebo.

2. They do not want to unblind the trial.

A. If the trial worked really well no one would want the placebo, no one would want to be in the trial everyone would demand drug. Same as 1. above. They clearly want both trials to proceed That's what the FDA wants.

B. If the drug worked poorly or showed no significant effect same as 1. No one would want to be in the 2nd trial. The second trial is different, different patients screened differently.

NOTHING out of the ordinary here. This is just how it works.

NO INTERIM LOOK until BOTH trials ready meaning full enrollment and just waiting outcome --- THEN you could " cheat " by taking a peak without risk

UNTIL THEN DO NOT MESS WITH IT - the trials are different MUST WAIT UNTIL FULL ENROLLMENT IN BOTH.





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