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gta888

10/19/13 1:25 PM

#18197 RE: HDGabor #18195

Yes changed and showed fda concern with approving for larger indication thus the question to adcom panel. Under the 10q amrn warned that this could be requested for. Bottom line is the risk to benefit analysis for them and adcom resulted in them feeling it could not be determined just yet so they safe side voted to wait. Had more focus and discussion on risk and benefits from amrn mgmt and fda, I feel adcom would have leaned towards conditional approval. Again I think worse case scenario is we get a crl in dec. We need to sell more and reduce cash burn like a traditional company without catalysts for the time being. The uphill battle, assess business and tone of mgmt during cc basically supports this. If mgmt felt there was an issue they would I think be more confident about next steps and tone would be defiant. Again, my assessment only.