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Wednesday, August 13, 2014 7:37:49 PM
We have known since March that the timeline for the PH2 trial was pushed back 6 months from July to first Q of 2015. That didn't change. Chip could have pushed it back, but did not. That really is not the end of the world.
There was always the primary request of the FDA to track LFTs to baseline, and Scarlet said "what takes a long time to happen takes a long time to unhappen". Geron needs to track down patients, get their IRB approval, get patient approval to take new blood samples, and then track the results- possibly for months.
This hasn't changed. There has not been bad news regarding LFTs- quite the opposite, MC was released and it is fair to assume the LFTs were not an issue. This will continue.
Geron is getting the Mayo IND at the end of September, however and even more important, they already have (or are almost complete) all the DATA from Mayo, and that is VERY significant. They are using that data "to inform the the new Phase 2 trial" which means they are certainly moving forward and the data from MC will help inform them on dosages, mylosuppressive effects etc. This is very good news.
The 33 patients still enrolled in the Mayo all have CI or PR or CR. That seems remarkable and also not fully appreciated. We don't know exactly the status of the MDS patients, but we do know that every single one is still enrolled more than 8 months later. I find this significant and almost astonishing.
Other than a few investors that inexplicably hoped for a hold release, nothing new or bad occurred on the call, quite the opposite. Time line still in tact. Data being transferred. Tefferi on-board. Patients in remission- MANY patients. Maybe a filing with the FDA after the transfer at end of Sept? Followed by release in Oct? Followed by by abstracts in November? Followed by ASH in December? Followed by upgrades in DEC?JAN? Followed by MDS studies in FEB? ETC ETC...
Take a breath. Let unknowledgeable traders abandon ship and long term investors make multiples of $$$
"evil flourishes when good people fail to act"
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