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Thursday, 10/24/2013 11:56:38 AM

Thursday, October 24, 2013 11:56:38 AM

Post# of 346191
BTD 26 goes to Alexion:

http://www.heraldonline.com/2013/10/24/5334916/fda-grants-breakthrough-therapy.html

I think it's safe to assume that if nothing is announced in the next week or so that PPHM does not possess a BTD for 2nd line lung cancer. This begs the question, "Why is Rob Garnick so content with a 600 patient phase 3 when the data justified a BLA submission before "the Fargo Incident".

Expanded Access Approval under a treatment protocol? BLA submission still in play based on phase II data? If not, it's gonna be a long couple of years.
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