Given a bit of reminder about the fact that half of opioid addition cases started with CLBP prescriptions, the FDA could surely be encouraged to think of a way to speed things up. When one appeals to common sense and reminds the regulator of the relevant facts, it becomes easier to specify and think about the problem. If the regulator can be persuaded to be more accommodating, then the Grunenthal deal immediately becomes more capable of being leveraged as the cash flows may be nearer term than otherwise would be the case.
Takeda has an interest in cell therapy but its focus there seems to be in cancer treatments. Its small molecule drug is for GVHD, not aGVHD. An interest in cardiology would be additive to its business and it is already a licensee of the MSCs through TiGenex, its European acquisition, for fistula, so they already have a business relationship with the company. How about that as an alliance partner candidate? (I know @Pharmagang mentioned Novo Nordisk as another possibility). They have also been building cell manufacturing capabilities in the US.
https://assets-dam.takeda.com/image/upload/v1706754932/Global/Investor/Financial-Results/FY2023/Q3/qr2023_q3_Expected_timelines_en.pdf
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