Indication intelligence, analysis and sector perception

Caladrius Biosciences (CLBS) an “iffy” CLI trial to proceed (?) with no partner in Japan

April 18, 2016 12:13pm

Profile-raising is not persuasive!

What good is an agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia?

The Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) thirty-day review period of the Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Company’s CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed … without further comment.

The Bottom Line: CLBS can’t procced with the pivotal trial which “they” say could initiate as early as late 2016 with what …? Who is kidding whom … in this matter, news that defines a negative for the sake of some visibility?

CLBS is UP +$0.03 on over-reaching “words” or hyperbole that won’t stick.

35 companies, 1 interpreter!

Insight, foresight and recommendation

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