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lasers

10/06/17 10:27 AM

#6753 RE: manisero66 #6752

Depends on the FDA's Dr. Scott Gottlieb and what additional information he is looking for. Once the trial begins, if interim results of 6 months for the Phase 3 are similar to the Phase 2B the FDA could award the Commercial BLA at that time. Otherwise could be 1 year results or as long as 2 years. It all depends on the FDA. The Phase2B results for the 114 persons enrollment were great which would be what needs to be demonstrated in the larger Phase 3.

https://clinicaltrials.gov/ct2/show/NCT01670981?term=aastrom&rank=9