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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-453

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    A pattern emerges: whenever someone says something reasonable, a target of attack is identified, a great red herring then comes up in a post immediately following, so that as people go to great lengths in correcting the poster, the original post and the reasonable argument (mine I try very much to support with good facts) is no longer near the bottom. and kind of lost in translation. Usually, the line of attack is someone is trying to lie or mislead.

    Let me suggest that the post that said attempt was targeting and no longer in people’s line of sight was one about the FDA’s own guidance on its own benefit risk assessments in doing drug approvals, and applying that thinking in the latest announcement on a possible AA pathway for Revascor for HF with LVAD, a device implantation procedure that started very much with Dr. Eric Rose’s heavy involvement. I would add that I believe his American accent, tongue in my cheek, that it is going to continue to be of benefit on this AA pathway. (Absolutely no one has to share my view.)

    Not financial advice.
 
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