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DewDiligence

09/02/12 11:10 AM

#89745 RE: keep_trying #89744

The Phase 2 was said by Dr. Garnick to have been designed with Phase 3 type deliverables in mind…

This is a statement devoid of any specific meaning that was intended to deceive investors, IMO. In actuality, the phase-2 NSCLC trial in question is very far from being a registrational-quality study for the FDA or any drug regulator in a major jurisdiction.

As previously noted, the ORR data reported in April are final and cannot improve, and hence the study in question failed to meet its primary endpoint and is useless for registration purposes, including accelerated approval.

p.s. Feuerstein is absolutely right that the ATM financing vehicle has not been terminated; if it had been, there would have been an SEC filing to announce the termination insofar as a termination would clearly have met the threshold of materiality for PPHM investors.