Interesting that all we heard about the FDA meeting on Revascor that has already taken place was on how the company explained the MoA* which they seem to have a good handle on, and the foreshadowing of the minutes - am I speculating in saying that they want something official in black and white to confirm the FDA response before releasing it to the market and in doing that, may be able to do something that is commercial in confidence in the meantime? Surely a lot of potential partners would have been waiting for this meeting to have taken place before showing their hand.
* Don’t forget that this has been publicly discussed by Dr. Perin, head of the Texas Heart Institute who ran the DREAM-Heart Failure trial (the results of which have been published) and is something that would have big pharmas salivating, since the MoA is different from that which is being addressed by heart failure drugs that are already on the market. In other words, it represents a non-overlapping complementary opportunity to the able and willing, and is something that will not cannabalise existing businesses . Given the stabilising of the interest rate outlook and the biotech sector (even if rates are to stay higher for longer), the need for big pharmas to deploy cash to replenish their pipelines, the excellent connections that Dr. Rose has in the US market to create low cost trial solutions (such as the one for adult GVHD that the BMT-CTN will be part funding and running), and the connections that are, albeit “dormant” in the case of Grunenthal and not openly promoted in the case of Surgcenter, already established with industry players in the US and Europe which can lead to operational if not financial support for the opportunities which are now much more tangible and near term than even 6-9 months ago,
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