$5.8 Billion, page-34

The same goes with all clinical trials ... there is an ethical issue with some patients receiving the treatment and others getting a placebo.

Although it would be great to ethically do so, I don't believe they will take the same path as GVHD where the double blind clinical trial was abandoned in place of an open label expanded access trial (as mortality rates were extremely high with patients on the placebo).

My logic is that the FDA recently agreed with Teva that the trial size be reduced to 600 based on the fact that multiple hospitalised events would be the key measure. In other words, the FDA and Teva find significance in clearly showing what impact the treatment has on # of hospitalisations.

As most patients have re-occurring hospitalisations - it appears there are adequate measure/treatments to keep a patient alive after a CHF event, but nothing has been able to work quite as well as MSB's MPC-150-IM to keep them out of hospital.