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Re: exwannabe post# 63945

Wednesday, 06/08/2016 12:14:45 AM

Wednesday, June 08, 2016 12:14:45 AM

Post# of 711602
Yes, I had forgotten this Ph 2 history for L, but that is what I was thinking of. Thanks RK for the review and exwannabe for the summary.

Reading the SEC filings that RK provided, it is not totally clear if there were any patients in the first attempt at a phase 2. They say they screened 50 and had difficulty actually enrolling... but don't say that nobody enrolled. I will assume you are right and those first few patients, if any, are not charted. Clearly they could not be part of the ph 3.

This does all tell me that the FDA was not being unfair in insisting on a crossover for phase 3. But no fingers pointed from me at NWBO either. Just a very difficult and somewhat sad situation; a situation spoken about by Biden in his address yesterday.
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