(Total Views: 437)
Posted On: 09/08/2019 2:14:35 PM
Post# of 155706
Without data, the phase 2 indications would add some, but not significant, just icing on the cake. An approved monotherapy leonlimab right now, my guess they could get $5B-10B. BP and Cydy historically I believe have been too far apart on Combo to agree on a deal.
https://academic.oup.com/biostatistics/articl...73/4817524
P3 to approval success around 75% for infectious disease, without bio makers it was 100% with low n=6... but still it would be in their best interest to include the occupancy test imo, as the FDA seems to favor that in approvals.
Anyway, assuming that is true, with p3 approval, I could see some BP rolling the dice with mono in play. Some upfront cash, plus milestone payments with revenue sharing for the mono prize, which Cydy would agree to.
What is disappointing is the tnbc trial delay, data there would change the play beyond combo+ mono.
All, imo.
https://academic.oup.com/biostatistics/articl...73/4817524
P3 to approval success around 75% for infectious disease, without bio makers it was 100% with low n=6... but still it would be in their best interest to include the occupancy test imo, as the FDA seems to favor that in approvals.
Anyway, assuming that is true, with p3 approval, I could see some BP rolling the dice with mono in play. Some upfront cash, plus milestone payments with revenue sharing for the mono prize, which Cydy would agree to.
What is disappointing is the tnbc trial delay, data there would change the play beyond combo+ mono.
All, imo.
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