I saw that mentioned on the FDA's website a few weeks ago, but my impression at the time was "it's just politics". It would be great if they would really apply what they say, after all, Osiris has been treating nearly all of the grade III and grade IV critical GvHD children for over 3 years now. You would think that the FDA would be ready to approve, but no...they keep asking more questions and for more data...even after Osiris already has 94 thousand pages of data collected and a proven 100 day survival rate of around 63%. If Prochymal is not used...nearly 100% of these patients die with two weeks and no other medicine works. Do you think the FDA could approve Prochymal right now?...no they need more information!
So, the FDA keeps letting Osiris treat these dying kids for free in the Expanded Access Program (EAP) and the adults just die, because Osiris can't afford to give Prochymal away free to everyone.
Shame on the FDA for letting big Pharma stall the approval process!
So sad that as long as big pharma lobbies and greases palms in Washington, that will be the case, Ozark. The only time(s) the FDA does the "right" thing is when the light gets shone on the overwhelming evidence that a drug/treatment should be approved. Remember when they tried to pass on Provenge and all of the DNDN people, along with consumers DEMANDED they take another look? 93K a treatment and it extends life by about 3-4 months? Right now SRPT is looking at filing for Accelerated Approval and, possibly, Breakthrough, also and they're trading at $33 with virtually NO revenue. Their product serves an unmet need for Duchenne (MD patients). Not that different a scenario here!!
Good find. Thanks. Try marketwiredotcom, then on page search fda and there it is. Here's a copy of some text:
"The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research."
Think Prochymal for AMI. I'm sure OSIR was aware of these developments. Could explain, somewhat, why AMI Phase 2 was extended to collect more data. So maybe approval with phase 2 data....preventing CHF and saving lives.