FROM SRPT ^Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care.>
Well, now we know Makary is a fool. "Swift action?" He knew about the death two weeks ago. He only acted when the market reacted. Plus it's not a "new safety signal" at all. It's the main well-known worry for years. The three deaths were in older bigger patients who had the maximum dose. All were in trials that were looking at safety. Why do you think they were looking at safety (and doses)? This guy is a lightweight and this statement is self-congratulatory bullshit propaganda. It's a joke. A publicity stunt. He will soon hear from real people, serious people. But it's great that he exposed himself. And that Prasad character who came with him is even more lame. And yet another blowhard. Where do these egomaniacs come from anyway? Thanks Bobby. Another slipshod shoot from the hip 2nd rater.
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