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exwannabe

04/04/25 5:22 PM

#759096 RE: attilathehunt #759042

Yes, the FDA mandated the cross over....


Wrong. Straight from the JAMA paper (the SAP in the supplemental content).

. When the Trial began in 2007, per the demand of investigators and patients it was necessary to include a crossover option in the Protocol in order to recruit and retain patients.



And though I no longer had the soource, LP said the same. And the discussion would have between LP (and NWBO) and the FDA, so I will take their word for it over parties not directly in the discussion.

Further, the trial originally was a P2. It was NWBO that elected to morph it into a P3.