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corpstrat

03/11/08 11:28 PM

#3761 RE: Bio_pete #3757

Yes, as I recall Joe said getting the FDA to commit to SPA would probably make the trial too exhaustive. Better to get results and see if they'll fly. Since he believes the drug is going to work very unambiguously - based on dat and moa so far - he's pretty confident that results will fly. It could be a very smart risk-reward choice. Do a quick, cheap trial and see what you've got. That's a business decision, not a science perfectionist decision. Amd of course it may turn out after the fact to have been a loser. Life's like that - no guarantees.
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quantumdot

03/12/08 12:20 PM

#3776 RE: Bio_pete #3757

All this rationalizing about how great a decision Joe has made by not obtaining a SPA for the anemia PhIII because it is a small, fast trial and this indication wasn't worth wasting time/money to get SPA on etc. etc. would ring true if RPRX was actually going to take the SPA route for their primary indications of UF and Endo. But to my knowledge they have no SPA for the PhIII UF program either which must surely raise an eyebrow even amongst the most loyal "stop asking questions" brigade.