Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-125

@Davisite Regarding pre LVAD ischemics you are right…but the statement today is regarding end stage heart patients with LVADs . A further pre BLA meeting will clarify FDA expectations for an accelerated approval filing …there is no requirement as far as I am aware for an additional trial before an accelerated approval decision in the latter indication. I was not expecting such a good outcome….so I am genuinely surprised that the FDA appears to have finally agreed on the MOA and potency for this indication. If the FDA minutes said something different to what has been reported Silviu would be open to massive lawsuits…so i feel very confident in my interpretation. To be honest , it’s in black and white in the statement so i should be telling the shorters to go where the light doesn’t shine …OP