I thought you were at some beach in Maine frolicking?
We are not jealous of INCY's comfort drug success but rather dumbfounded it defies any pure logic.
INCY's drug dude is below average, in fact a complete failure when it comes to clinical remissions. He probably bribed his way through med school.
Van you forgot to mention how your mediocre underachiever who transforms himself into a successful, supermodel dating biotech leader has also become an FDA influence peddling bully on his pharma turf using the $B's he's made selling snake comfort oil to unsuspecting cancer patients meanwhile hurting the competitors ability to market a potentially life saving drug.
Facts speak for themselves. And the fact you are on this board promoting INCY speaks loudly from which lobby you're funding originates.
Every trial protocol is reviewed by FDA bfr. trials are ever approved. LFT reversibility follow up when the company was hit with this request twds the end of the P, ET proof in concept protocol reflects bad on the FDA's lack of consistency. None of GERON's previous trials(2 years of breast cancer trials) were ever halted for LFT concerns and yet this one, after showing CR's & PR's in the MAYO trial, a first in MF oncology treatment IMET was slapped with a full clinical hold.
To me this all points to the work of the INCY lobbyists effectively at work on the FDA. Why hasn't Jakafi ever been halted for all it's serious toxicity issues? And yet the INCY "comfort drug" moves on gaining more indications based on weak comfort criteria.
Maybe total conjecture Irish but it would be priceless if indeed this was really the behind the scene story. Scarlet did repeat "high unmet medical need" at least several times in the CC. BTD is still possible. Now that Tefferi is in charge of the clinical trials & the FDA's appeased by this move possibly suggests BTD status might be @ BAT.
Isn't this a possible blessing in disguise because data not under the ASH submission embargo can be presented anytime such data becomes available? Such news would support IMET for a broader MDS indication base.
Chippy mentioned them in the CC and stated Tefferi hadn't the tme to review that data to submit it in the ASH data abstracts but would at some other opportunity.
which means he's free to present abstracts for other indications not under the ASH submission embargo any time now.
Hopefully this year he slips more info pre ASH. The blast phase MDS data is not under ASH data submission embargo.
...good post E2 even if you didn't listen to the CC yet. I agree something smells fishy in the state of Denmark for the FDA to have forced GERON around all these roadblocks.
In the end of the day IMET in terms of efficacy has met the golden standard of remissions which even INCY and the FDA cannot deny.
Hopefully Tefferi presents some blast, MDS data update on other indications in data not under ASH data submission embargo. This would further help validate wider indications. With the ET & PV hold in place many more of these previously treated patients could develop advanced MF where only IMET can promise remissions.
Only disappointment was no mention of Chippy going fur BAT. Or maybe he's keeping that one guarded.
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.