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noretreat

08/16/14 5:48 PM

#65463 RE: rule_rationale #65460

Rule_rationale, you rule! I've been here from the same point. Loved that 6x! 2012 had a few of those...

Don't know what is going to happen next here, don't even know what has already happened in trials of K, B, or P. Lots of open questions right now.

BUT

Have heard nothing to suggest that patients in the B trial needed secondary treatments, so my take is that B and D are both working well...which of course would favor B for reasons endlessly discussed previously.

Don't think anyone would opt for continuing treatment with K if there were no positive results. A favorable B result would make me comfortable with about 3 more K cohorts.

P...who knows? But at least it passed the first hurdle. We should get more on P this week if management's time frame holds....regarding P, Mr. Ehrlich provided the following on August 7th, and "late next week" would have been yesterday.

The game plan is to receive the final report late next week. Then, select vendors from the bids that were tendered to us (next week). Review the protocol with the sites selected for the trial. Prepare a meeting with the fda for guidance on any questions we may have. (Before each phase, you are allowed one opportunity.) Complete FDA meeting and file protocol for phase 2/3. The longest part will be waiting for FDA meeting, appx 30-60 days. All other steps will go relatively quickly. Realistically a 3-4 month process because we've already done all the prep work.
Leo