Seems to be an overreaction - they HAVE met the primary endpoint - FDA have given them RMAT designation for primary endpoint of reducing bleeding.
Bleeding is severe and life threatening in this disease and costs $40,000 per patient every time they are readmitted to intensive care. MSB treatment will cost $US50,000 to $75,000 and has met the FDA primary endpoint.
Weaning off the LVAD was not the FDA's primary endpoint.
I think the reaction has been fairly simplistic and is a lot more nuanced - there was a lot of expectation going into this announcement and it was probably going to fall no matter what the outcome. Anyway, this indication is only 6% of analysts' valuation of MSB - and it worked!
SI and his team are giving a conference call from the US tonight (in about 12 hours) no doubt they will be talking to the assembled heart experts and pharma companies attending the conference in the meantime.
This could all turn around again in the near term if someone decides to partner with MSB on this indication which has met the FDA's primary endpoint on reducing bleeding and has an RMAT designation.
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Seems to be an overreaction - they HAVE met the primary endpoint...
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