Indication intelligence, analysis and sector perception

Pluristem (PSTI) PLX-PAD P3 trial - the hype endures

July 27, 2016 9:19am

Key verbs “being designed, intends, plans and discusses pre-submission meeting with FDA, last but not least could improve”. A little early to be touting to … “Improve recovery following surgery for hip fracture or even femoral neck fracture” – the wagon is in front of the horse as the pre-market shares jump 4% to $1.55

Pluristem advances towards multinational P3 trial of PLX-PAD to improve recovery following surgery for hip fracture or even femoral neck fracture

PSTI has already submitted the protocol to the European Medicines Agency for a single pivotal study in this indication
P2 data showed PLX-PAD’s strong muscle regeneration capacity following total hip replacement surgery
Patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume six months after surgery, as compared to the placebo group.

The Bottom Line: PSTI looks forward to … working with the FDA and EMA and to … receive clearance to commence the trials – when completed and approved is when the announcement should be rendered. The usual hype and hyperbole – when will they learn? Next question, why did licensee United Therapeutics (UTHR) walk again …?

PSTI closed at $1.49 DOWN -$0.02; the shares will jump and then do the usual – let is run and then DUMP.

35 companies, 1 interpreter!

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