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Biotech / Medical : Biotech Valuation
CRSP 56.52+0.2%3:50 PM EST
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Lance Bredvold
To: A.J. Mullen who wrote (51711)4/6/2021 6:18:08 PM
From: A.J. Mullen1 Recommendation  Read Replies (1) of 52153
 
Good call, worth listening to the recorded version. They say they can no longer claim superiority roxadustat incident dialysis. Now they claim it is comparable to EPO for MACE and MACE+, and they continue to claim roxadustat is comparable to EPO for those risks.

For each risk and in each setting (ND, DD and ID), the numbers are slightly worse - higher bounds on all confidence intervals and higher point estimates. It's fair to say the numbers don't show roxadustat is either better or worse for those risks. The company will argue that their drug is much better at controlling anemia and there's no reason to expect it to be proven to have lower risks than the existing standard of care. In answer to a caller, the company stated there is no prespecified hazard ratio that the FDA has determined is a bar FGEN needs to get under.
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