Biotech Values

[genisi]

Xarelto in ACS data

Urche,
On the discordancy in dosing between Afib and ACS: different indications for different populations on different background therapy and I agree that an additional study will be required but IMO only in the overlap population.

On intracerebral hemorrhages: looking at Fig. 2 in the NEJM paper, the subgroup of patients with previous stroke or TIA had the worst data and I'd expect they also had the majority of intracranial hemorrhage events.

On NNT and NNH values, your calculations are correct and like you said, we're looking at mortality benefit vs. increased major bleeding but I believe it will be considered a significant net clinical benefit.

So, my point is that IMO the decision to use riva in ACS is far from clear cut.

I expect the FDA to have concerns with xarelto in ACS similar to your but my bet is the lower dose is approvable. Let's talk about the decision to use Xarelto in ACS if it gains approval in this indication :)

Respectfully,
Idit