So without the M2 group of patients, that have no benefit of histamindicloride, the figures for the whole patient group on O S turns out to be really interesting.
As you see the OS figures are significant.
Also note that when you reduce the patient group by 25 % taking the M2-patients away (out of the US-study, is today's issue), the remaining patient will live longer or stay alive so that the impact on the commercial effect is far less than it seems at first glance. Using the "old way" of calculating the size of the acctual patientgroup we have:
70 % remains alive after first Chemo therapy, 25 % of them have stem cell transplantation - and with the new more precise patient group with better chances for O S, there remains 4 750 from 13 000 gross in the USA. The same figure for the EU is 5 880, 16 000 gross.
As the new target group will have a bigger chance to survive the market penetration of the group above will better, cet par.
The price for one whole treatment is now appr. 65-70 000$, depending on the Euro - USD rate.
I think it would be nice if there were a press release giving some explanations to the data in the presentation above.
The data creats an info gap in the market. Please, fill that gap.
The content, a p-value of 0.0299 for Overall survival, is not sensational, but at least, a very important fact bringing to the table negotiating a SPA-protocol.
What we are dealing with is a very much higher probability of being approved by the FDA in the US. Investors should try to relate this news to the trial design that management have proposed to the FDA. What will the p-value become if all the changes will be implemented?
And, histamine dihydrochloride it is. Nothing else. :-)