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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.

MSB Price at posting: 33.0¢ Sentiment: Buy Disclosure: Held
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https://www.sciencemuseum.org.uk/objects-and-stories/how-was-peni...

Collaboration in a green (steel) future the focus for Magnum and Saudi partners

GreenX picks up prospective copper project in Germany

Is oil undervalued?

Cost blow-out for Rook I uranium project sees share plummet for NexGen

Week 31 Wrap: JORC rules to get tougher; RBA rate hike chance 50/50; US Fed Sept cut still the quo

Vmoto sales plummet -50% YoY as weak demand in Europe & China stifles EV scooter sales growth

Venture to sniff out high-grade REE targets at Jupiter project, WA

Commodity house Trafigura funds Develop Global's copper-zinc Woodlawn play with offtake deal in place

Westgold sets its sights on top five producer status through merger with Karora

Uranium prices on the NYMEX are stable, but ASX uranium stocks are sinking on Friday. The answer lies in Kazakhstan

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https://www.sciencemuseum.org.uk/objects-and-stories/how-was-peni...

Top Stories

Collaboration in a green (steel) future the focus for Magnum and Saudi partners

GreenX picks up prospective copper project in Germany

Is oil undervalued?

Cost blow-out for Rook I uranium project sees share plummet for NexGen

Week 31 Wrap: JORC rules to get tougher; RBA rate hike chance 50/50; US Fed Sept cut still the quo

Vmoto sales plummet -50% YoY as weak demand in Europe & China stifles EV scooter sales growth

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Commodity house Trafigura funds Develop Global's copper-zinc Woodlawn play with offtake deal in place

Westgold sets its sights on top five producer status through merger with Karora

Uranium prices on the NYMEX are stable, but ASX uranium stocks are sinking on Friday. The answer lies in Kazakhstan

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