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Pluristem (PSTI) a glass half empty or half full, yet another trial to validate platform

December 21, 2015 10:28am

PSTI reached agreement with Japan's PMDA on protocol for “final trial”? In what time period again, - SELL

PSTI has reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI).

The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan’s new accelerated regulatory pathway for regenerative medicine.

The Bottom Line: Another trial, another 75 patients suffering and another 1-2 years. Stop speaking “in tongues”.

Efficacy and safety will be determined from outcomes measured nine months after administration of the first dose. The primary efficacy endpoint will be diagnosis of a patient as CLI-free for 60 days. Pluristem expects to submit the formal Clinical Trial Notification (CTN) to the PDMA, based on the agreement reached with the regulatory body, in early 2016 – I THINK PSTI means 2017 or they’re not counting right - AGAIN.

PSTI closed at $1.18 and is DOWN -$0.02 to $1.16 in the first hour of US trading markets

35 companies, 1 interpreter!

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