Change management? Why? Chippy didn't accept a low ball offer.
This has more to do with the INCY lobby than anything Chippy did or did not do. The ET & MM data from GERON's proof in concept IND study was the basis of the FDA's hold. All required data had been previously submitted by the company as advised by the liver experts they consulted & the FDA which gave initial approval to run the trial and required data. (Hy's Law). The FDA's timing; waiting till nearly after the study was completed to implement this clinical hold, allowing a full year to elapse prior to informing the company of the LFT follow up data needed. This timed with the stellar MAYO MF results raises question if the FDA acted independently or was influenced. The company was surprised by the FDA's hold & request with GERN's IND as it followed the unwinding of these studies.
According to the CC any updated MF trial data will have to wait till ASH which is under ASH abstract submission embargo. Dec update expected with a hold lift possible bfr.
MF's MDS & Blast phase data was not submitted by Teferri for ASH as time constraint on submissions to FDA partial lift was addressed and these updates were not available as a result. He will present this at another forum, possibly sooner than ASH.
He means latest (newest) brochure from MAYO. What's noteworthy is that they don't even mention INCY's Ruxolitnib as a treatment for MF under their hematological cancer heading. Remissions trump comfort at the MAYO.
"Facts do not change with time. My views on ruxolitinib and other JAK inhibitors are based on facts from clinical trials and personal experience in using these drugs and they are comprehensively outlined in my recent reports in NEJM, Blood and the Mayo Clinic Proceedings Nothing has changed since other than the expected relentless effort by the drug companies and their sponsor-friendly colleagues to undermine important patient safety concerns and the therapeutic limitations of ruxolitinib. I, for one, have no interest in being a pharmaceutical sales scout and would rather spend my time and energy to seek new and better drugs for my patients. I am old enough to have seen a similar scenario in the past with the use of anagrelide in ET and PV.”
time will tell. Monday should clear up some of the confusion going fwd. We'll see who's side Chippy is playing ball for. He's up at BAT come Monday.
drug specific genetic oncology is the big medical push today. IMET is one such drug that has met this criteria in that it is gene specific and can sustain complete remissions in MF and AML patients.
Unfortunately already passed too many wood 'chippy' looking pellets without ever feeling filled.
To me Irish this reads like a red herring smells. Clearly the FDA appears to be acting complicit with INCY in preventing GERN's advancement in other applications such as ET, PV & AML's. Instead INCY with a jack all ``comfort`` drug worth billions to them has deceptively cornered this market. Unfortunately the patients being treated with it are never cured nor experience remissions and most discontinue as a result of serious side effects.
good point Ryan and by the number of thumbs down smart shorts have probably realized what the market is missing and hope to cover bfr. Phase II is publically announced.
Irish please repost this from time to time. It becomes hidden amongst all the drivel. With Yahoo's lousy new format good informative posts get buried too quickly.
Once the MC IND is transferred to GERN in Sept. all data becomes property of GERN and the company will be free to disclose any relevant data to shareholders. All data requested by the FDA for MC IND phase 1 has been submitted, reviewed and accepted.....hence their hold release. This allows the company to proceed under the MC's IND to phase II as Irish has pointed out.
ASH will be another big boost but by then we should have materialized into a much higher SP.
The MM ;=3) has obviously no sense of urgency to cover his short position and is taking his sweet old time. With lower volume his job will be much harder going fwd. Who knows maybe Chippy will surprise us all with something he'll pull out of his acorn lard next week, god knows he's had enough time to gather plenty of nuts.
Shouldn't you be on a cruise?
Gerny has finally set its sails. Now get those naked shorts to cover up or toss them overboard. Chippy's at the helm, Teferri has set the sails, the sun is over the yardarm...INCY's walking the plank...time to toast the ride. Let's break some waves!
Firstly it's not just one product in their hands...it's the Holy grail of MF treatment.
The company needs to take back control in order to initiate phase 2 testing and apply for BAT designation. As a contractor to GERON the owner, the MAYO cannot initiate such progress. Tefferi is still running the trials.
Chippy can now BAT this out of the Menlo ball Park
That ends the veil of silence on the data results. INCY just got kicked in the acorns by Chippy
goodbye IMET Mylelofibrosis 1ST, welcome IMET Mylelofibrosis 2ND
At some point this was inevitable. As a contractor the MAYO, as great as they are cannot apply for any special case FDA approval on behalf of another company's drug. This must be done directly by the company. We shall get updated data results sooner than ASH in Dec. by this change.
Chippy is now in the driver's seat for better or......
just read my answer "The Company does not intend to enroll additional patients in the Myelofibrosis IST and plans to continue to conduct the Myelofibrosis IST at Mayo Clinic until the trial is closed. Dr. Ayalew Tefferi will continue as the principal investigator for the trial."
What happens to existing patients in the MAYO trial? Will they have to commute to Menlo CA. for treatment?