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gavint66

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25/03/24

14:20

Post #: 73044779
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Originally posted by irenekwshiu: ↑

This means a lot, and I mean A LOT, if the company takes to heart what Peter Marks said in the video in support of Dr. Verdun’s point about communication. Take good, specific questions to the regulator with supportive information in exchange for informed, helpful responses.

Can anyone not sit up and pay attention if in the course of talking about HF with LVAD in a pre-BLA meeting they are also given the sub-(ie. inflammatory) group analysis from the DREAM HF trial, especially if also told about the nascent but very exciting nature of research into the whole area of inflammation?

Can one not also sit up when one gets asked about how EAP can be used to give good signals about early efficacy in the CLBP trial, that they are also made aware or get reminded of the pain-inflammation nexus and Opioid-back pain angle, and can one not start wondering if this could be a solution to a huge problem of addiction, in the same way that the vaccines for Covid were developed as a solution?

I think getting these alignments with the regulator in the way that is actively being promoted by the regulator right as we watch the video, has huge implications for the speed to market of the company’s products. I have said a number of times to the company that one of its most difficult tasks is to inform the market as well as the regulator that what it is attempting to achieve just may not be too good to be true - not some magic as Dr. Perin said. Getting a buy-in is not a trivial task because it can sound like stuff for fairy tales, but a sense of progress or that it is within reach is definitely there on the part of industry participants including the regulator, as to how proving up the pudding by eating is possible. Collaboration is key.

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https://www.sciencemuseum.org.uk/objects-and-stories/how-was-penicillin-developed#:~:text=1928%20to%201929,chemical%20that%20could%20kill%20bacteria.

Sometimes it takes 20 years to prove that something miraculous works and then it becomes the standard of care.

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