Marks was the bane of MSB holders lives for years....until of course MSB was approved. Lots of stone throwing at Marks on Hot Copper when people couldn't find someone/thing to blame for regulatory and commercial advancement of their company and now sowing of FUD on CYP threads by our usual (un)friendly detractor of all things CYP.
More pertinently to this thread, MSB just, rather remarkably in the eyes of many recent institutional sellers of stock I am sure, gained Medicare and Medicaid confirmation despite a whopping wholesale acquisition cost of US$194,000 per intravenous infusion - treatment involves eight!!Whilst frankly mathematical inept Hot Copper posters obsess over shorters as the sole blame for MSB falling from a $4 billion (!!!!) stock with very little commercial sales, to a more reasonable, but still massive $2.5 billion stock, many professional holders would have been simply taking profits and reducing risk on treatment pricing fears and wider systematic market beta selling.
This thread is "CYP Price Target post MSB FDA approval".
CYP is a $40 million funded phase II and III trial stem cell company, with a phase II trial in GVHD. Our mocking friend likes to mock Killian's Sep24 suggestion that CYP might, might, not need a phase III trial to gain GVHD approval. It was only suggested as a possibility, but ironically the chances of that have improved, with MSB's approval and acceptance by Medicare/Medicaid - its was a risk IMO given the huge price (and I hold MSB).
Only the most ignorant of MSB shareholders would deny MSB convincing the FDA of continued potency strength and consistency issues (which CYP's procedure of course avoids) was the main hurdle to prior approval, in it bone-marrow, multi-donor, derived Mesenchymal treatment that sees undeniable degradation in cultured expansion - a single dose requires some 200 million MSC's. CYP does not have that problem with its IPSC scale and potency quality consistency manufacturing benefits.
I believe Dr Kelly originally said some something like 'it’s possible that the drug could win approval in the US without a phase III effort because it is a rare disease with a significant unmet need.'. Now admittedly, he might change that to, 'its possible that the drug could win approval in the US without a phase III effort because, MSC treatment has already been approved, and it is a rare disease with a massively expensive treatment, that we can significantly undercut'.
Forgive me if I tell you stuff you know, but approval aside, Eli Lilly paid Incyte $35 million in upfront payments alone for Ruxnolitnib back in 2016, as a certain broker keen to point out, but does not point out that it followed wide worldwide rights to develop and commercialise for all inflammatory conditions for $90 million and up to $665 million in potential milestone payments.....back in 2009!
Now many MSB holders will naturally be hoping for a heart related partnership to emerge (I know I am). But if you are big pharma (and again I am a MSB holder) do you want to be negotiating a deal with a $2.5 billion mkt cap company, that is yet to be approved in heart and other applications, or a $40 million company without the scale, potency, and quality issues that a multi-donor appoach takes?
(20min delay)