Page 1 of 1

What to expect in the next month

Posted: Thu Oct 10, 2019 11:33 pm
by biopearl123
I think we might see some activity on the following fronts: 1. Announcement of first patient dosed (imminent) along with an update of addition of new sites (North Dakota, Israel etc as outlined in new side presentation) along with changes in status to active in sites now designated as completed or inactive. Guessing we will have perhaps 70 active sites at onset of study (I think the Russians will have a lot of interest in the treatment of MDS given their contribution to the world's radioactivity quotient). 2. Pubic release of ASH abstracts on Nov 6th. Expect we will see actual overall survival numbers for MF study (remember that MOS is a surrogate for actual OS). We may get some insight into the TN patients and almost certainly some molecular end point data that may strengthen the anticipated presentation of data to FDA in Q1. For MDS watch for durability data. AFAIK, the TI interval has stretched into years for some patients, have not seen similar data anywhere else. Also molecular end points and bone marrow data might be available. Geron may also find a way to highlight the newly initiated part II of the MDS study. Considering that meetings with KOLs are done (and we know what they think), we should get some idea of what is going to FDA from the abstracts in MF including a look at a critical statistical evaluation of the previously discussed Italian study. After ASH it should be pretty transparent as to what Geron plans to present to the FDA Q1 and what our chances are for some form of conditional approval. bp