"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.”
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.
"Tefferi of the Mayo Clinic in Rochester, Minnesota, gave follow-up information on the reversibility of hepatotoxicity for all patients who received imetelstat in the MF trial, and the FDA informed him in a letter Wednesday that the trial could continue"
So now that MF1 trial can continue the multi centred larger cohort trial can proceed. The FDA was obviously satisfied by the MAYO's LFT reversibility data and could not further deny a clinical hold in place on MF studies. Reversibility is achievable. One cancer down, how many more to go? JAKI a far inferior treatment was given borrowed time by the FDA when granted approval given it's serious side effects.(approval likely bought and paid for). This lift means GERN will prevail and that IMET can & does save lives; this nobody can deny..
Congrats to all those especially Irish and John that have gone to bat to get this done. Thankyou. And above all fur answer to prayer that this hold will be lifted to enable MF patients to benefit from the treatment.
Now Chippy get off that golf course and into the ball park to get that phase 2 BAT application batting average up to snuff. You need to hit one out of the park. The ferri did his part, now it's your turn.
the MAYO MF trials were with 3rd & 4th stage patients that had no other options. Without seeing all the data Ièm thinking the FDA`s reversal was taking into account the severity of the prognosis weighing it with mild LF elevations that have appeared to be reversible. PV & ET wasn`t in the same category but you`re right in that JAKAFI with many severe side effects is still expanding it`s indication applications to the FDA reaping $billions on a slight reduction in spleen size attribution but has yet to show CR or reversal of the cancer.
CEO compensation should be tied more to shares than salary. Having such a disconnect as we have seen here doesn't favor shareholder interests very well.
INCYE wouldn't require combo therapy if they had a drug that could offer clinical remissions like IMET, soon to become complete remissions without toxic side effects like their lead candidate RUX presently does. With a $20 decline in INCY's SP the current value of GERN should be $20. After phase II or fast tracked BAT designation it will be much higher.
Again Irish thanx fur keeping us critters abreast of John's progress. I do acknowledge your sacrifices in this effort to save his life and others afflicted by this disease. As investors we are driven by a profit motive which if it comes to fruition are bountiful but dwarf in comparison to the gift of extending the life of a loved one. My prayers in the Pugwash Chapel today are fur all the IM patients, the MAYO and fur the powers to be to lift the hold on IMET.
....what possible catalysts prior to Nov.? The hedge fund shorts are all over this "quiet time" period lapse. Nov is not soon enough.
B) FDA release on hold?
C) MAYO expanding it's study on IMET?
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.
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!
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.
...what big gain? It's merely heading back to where it was bfr the FDA retardedly placed the drug on a full clinical hold.
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.
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?
Sean Williams writes "On one hand, Geron's imetelstat is extremely intriguing in that it's the first investigational therapy to show clinical benefits in treating MF and delivering partial responses in its IST rather than simply mitigating symptoms. However, Geron's pipeline lacks depth, and its full clinical hold pertaining to its in-house studies for polycythemia vera and multiple myeloma remains in place. It's another stock I'm perfectly happy to watch from afar."
He fails to mention IMET has delivered Complete Clinical Responses or remissions as well as Partial Clinical Improvements for several MF patients. If Geron's pipeline lacks depth INCY's is nothing but a smokescreen billowing $billions of profits. Sean will be watching the SP double from afar when the complete clinical hold is lifted.
I almost choked in laughter whilst swimming and reading this on my water proof Ipad. INCY has a $10Bil market cap for a make belief relief drug Jakafi. GERN has the drug for remissions. I hardly think $4-$7 would even come close to IMET`s potential. I`ve seen scenarios where SP could rise to $40 on such speculative potential.
funny my take was that the FDA was the one wearing ineptness on their face. Obviously they leaked the most recent lift news. What else have they messed up with I wonder?
Hedge funds made a killing again.
Wonder where are all the ambulance chasers are seeing how GERN is on the Gerney, AGAIN?
They need to launch a class action against the FDA for this frivolous hold on IMET. Enough is enough.
as I posted the WHO's categorization of ET, PV and PMF all to be myeloproliferative neoplasms (MPNs) are characterized by the clonal proliferation of one or more hematopoietic cell lineages, predominantly in the bone marrow, but sometimes in the liver and spleen.1 In contrast to myelodysplastic syndromes (MDS), MPNs demonstrate terminal myeloid cell expansion into the peripheral blood. If IMET works on MF what's to say it won't be effective on other similar MPN cancers such as ET or PV?