Friday, April 20, 2018 4:47:52 PM
Count me in that group for sure!!!
(and YES!!, I can verify that "Eich" has been saying that "all along")
OR NOT, maybe it's ..... GOOD NEWS coming out!!! (that's my bet)
BTW, repetition is NOT an argument!
(check out the work of Dr.Tobias Winkler's group (muscle regeneration),
and the outstanding results they've been getting.
That's based on real data, generated by actual clinical studies,
by highly competent, credentialed scientists and clinical specialists).
We have seen strong data in all of their current target indications,
so to assume "bad news" is a non sequitur (and unjustifiably pessimistic!!)
2016.08, announcing CLI P3 start approval by FDA:
"Data from the two Phase I studies showed a favorable safety profile and promising data on amputation free survival one-year post-treatment, improved tissue perfusion, and a reduction of ischemic pain at rest."
"This Phase III trial is intended to support a biologics license application (BLA)."
2017.01
"PLX-PAD cells have been selected by the European Medicines Agency (EMA) to be developed for CLI via the Adaptive Pathways pilot project. Under this regulatory pathway, the multinational Phase III trial may potentially lead to early marketing approval of PLX-PAD for CLI in Europe, based on interim efficacy data from the first 125 patients that have completed a follow-up of 12 months. Data from the entire 250 patients will be submitted to the U.S. FDA for a Biologics License Application (BLA) targeting commercialization, and to the EMA to apply for full marketing approval."
2016.08:
"In one of its most encouraging trials in CLI, there were zero cases of limb amputations or deaths during the 12-month follow-up period after administration of these cells."
All of this bodes well for a successful outcome!
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