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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-96

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col69

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11/03/24

11:55

Post #: 72839283
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Originally posted by otherperspective ↑

@DocMcstuffins I am afraid you do not understand what is going on. If my understanding is correct there will be a pre BLA meeting in the next few months followed by a BLA application approx six to nine months later. Regarding economics , LVAD patients typically undergo a typical procedure costing around US$150k with further after care costs of approx US$750k in the two years after. Based on the ischemic sub set clinical data in the original trial response rates , the procedure should reduce total costs by between 70-80%. On a back of the envelope QUALY formula basis I think the 150m allogenic MPC cells required could attract reimbursement around the US $200-300k mark per treatment . The initial market would be 2000 odd ischemic LVAD patients but with poor outcomes from existing treatments I believe a much larger percentage of the 100k potential market will seek to access this procedure. LVAD could become a destination therapy of choice for those not eligible for a heart transplant !
The obvious follow on is the Coronary Bypass market of 50k patients a year where the cells could be easily administered as an adjunct to the bypass procedure. That would obviously require further clinical data ..but the case for using off label would be compelling once the LVAD procedure is cleared.
To be clear , the FDA appear to have given Mesoblast the opportunity to file straight away for approval in the LVAD category without a further trial needing to be done suggesting they have no issue with the potency assays required for this indication. I would, however, anticipate the larger indication of Pre LVAD ischemic patients (one of the biggest potential markets in US healthcare worth many billions ) to require a further trial. We may just have to make do with a several hundred million new market opportunity in the meantime.
If Silviu can’t get partners for CHF now , i would be shocked. OP

Please do not rely on the facts and opinions expressed in this post when making an investment decision.

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Yes @otherperspective it appears the Doc's on here don't seem to understand what a BLA filing is given they still claim that more trials are needed prior to said submission ?

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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-96

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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-96

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