Sunday, April 17, 2016 8:02:11 AM
As for the breakthrough designation the FDA is always a cautious bunch. YOu see recently two or more biotech stocks get halted for safety issues? ADXS trial was halted for one patient death, until FDA could determine the drug didn't cause the problem.
As for Orphan Drug Status for the phase 2 GvHD trial it is a good thing that there has not been a response. If the FDA was truly not interested in granting the Orphan status they would have already rejected the application 30 days ago.
Therefore I don't agree with your statement!
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