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fuzzyforeigner

06/17/13 3:44 PM

#78170 RE: Inoviorulez #78166

the FDA does not approve based on that. im sorry. The FDA approves based on efficacy potential and patient safety. that is it.

YoungBuckTrader

06/17/13 7:11 PM

#78231 RE: Inoviorulez #78166

We,re talking about an IND. Come on, they didn't deny it when it was first submitted, why would they request more info and create more work for them. They know this has the potential to become a novel treatment for a unmet medical need. For new comers... PSTI got FDA approved and orphan status for same disease as bmsn... In the bag imo