By: provocateur
I have a hard time with PFS data when the FDA , we know will demand OS Data
View ArticleBy: David
How you say the odds of filing in the EU is zero, when they were going to file on PFS and NOT OS. So drugs can only be filed if they hit the primary and every secondary endpoint as well? If you dig...
View ArticleBy: Ohad Hammer
Theoretically, the p3 trial might still be successful but recent developments decrease the odds for such an outcome. I don’t see anyone approving this drug based on the p2 data, even when all of the...
View ArticleBy: David
Fair enough and I understand that government agency can go completely against their previous guidance but if it were approval on a PFS primary endpoint, why would the EU suddenly decide to change its...
View ArticleBy: Heymang
Ohad, Thanks for your hard work. MITI has started to really move to the upside. Do you think they could do another secondary or is a buyout a possibility? Do you have a price target to unload some...
View ArticleBy: Ohad Hammer
David- remember we’re talking about subgroup analysis from a phase II. You might be right if this were a p3 data set. Heymang - The current price level fully represents the ALL opportunity pursued with...
View ArticleBy: Ohad Hammer
Not following it closely. They seem to build a diverse early stage pipeline to complement fostamatinib. Ohad
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