I am hoping for quick approvoal for LVAD bleeding for the heart...

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joeycav11

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05/04/19

17:59

Post #: 38018705
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Originally posted by Anjo-Roch: ↑

Except - we have GI Bleeding / LVAD FDA meeting coming up this quarter (June 19). Reading the announcement again (regarding the confirmatory trial for reduction for reduction of Gastrointestinal Bleeding in LVAD patients) , IMO the decision by InCHOIR to enter in MOU with Mesoblast is not made without detailed technical review by InCHOIR regarding what they understood in the recent 159 LVAD patient trial.

IMO, to me is sounds a bit like "Oops .. we think we got the wrong endpoint .. lets get the right endpoint this time".

And I greatly commend InCHOIR for entering into the MOU. At the end of day, its about improving patient care.
At present , IMO there would be a good number of very sick patients that do not receive LVAD because of GI Bleeding risks and related consequences. I'm looking forward to the LVAD FDA meeting this quarter. The way I read it, is that a possible scenario under RMAT is for the FDA to look at the data (and if the safety and efficacy stack up) , they recommend to Meso to put in a BLA on GI Bleeding reduction and continue with the confirmatory trial with InCHOIR.

This would be a wonderful thing for all stakeholders ( patients ; families ; hospitals ect). For MSB, its another opportunity as this application could extend the broader market for patients that are currently not able to go on LVAD's because of the risks of GI Bleeding (let alone the current older Ischemic patients that do go on LVAD and were part of the 159 patient trial).

In as far as DREAM-HF-1 trial (P3 Revascor) is concerned, I would encourage all to go back and go over the February 2019 newsletter with respect to the read-through from the November 2018 LVAD trials . Now read this in context of the recent MOU signed with InCHOIR.

In my opinion only, a partnership could be made ahead of any DREAM-HF-1 trial results
(excluding potential CLBP partnership).

Good weekend to all.

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I am hoping for quick approvoal for LVAD bleeding for the heart .Truth is so many drugs and devices have been approved that did not show anywhere near this amount of efficacy.Second without side effects.
Approvoal of this smaller indication will ramp up manufacturing for the larger trial taking place. Time for FDA to get onboard and move these therapies to the patients.

MSB Price at posting: $1.41 Sentiment: Buy Disclosure: Held
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