I posted this back in January, half joking at the time,"...it always happens with new drugs. They get approval for one indication and then start tweaking the drug for another. Viagra started it's indication as a flacid obesity drug. Needless to say it's pipeline profits didn't 'arise' till applied to it's current indication. Who's to say they can't get IMET to work maybe with another RNA telomerase inhibitor to work on solid tumors or better yet on erectile dysfunction. Much too early to say." Never thought of the hair loss angle till Irish started bringing it up but I have to say it that would be a multi $Bil market. Certainly lt would cure the SP's current erectile dysfunction.
realized after I read it...but I hear you bro, this SP gaming is unnerving especially if you are holding.
E2W it appears your quoting the Fool's article but without "quotations" comes across as your personal thoughts. Joanie thought you jumped ship?
Haven't there been almost 18 months EL results from MF phase 1 trial? Had it not been for extenuating circumstances this could easily have been given fast tracked designation
"Previously, the FDA had asked Mayo to halt imetelstat's use unless patients in the trial were already responding to the drug. Mayo was also tasked with demonstrating to the agency the reversability of any liver damage that might be caused by imetelstat.
Since the FDA has lifted that partial hold on the Mayo study, it would appear the clinic was able to satisfy the regulator, and that might indicate Geron could similarly win over the agency regarding its own in-house trials"
he lacked much of the trial specifics surrounding the data, the partial hold being lifted, IMET's other potential indications. The complete remission data. As above I hope I helped enlighten his view & perspective on Imetelstat.
INCY's SP hasn't exactly been rallying from it's high of $70 this spring. Awaiting PV comfort indications approval this Dec. but based on earlier test results it was lackluster; hair growth wasn't even mentioned as an endpoint. Based on comfort endpoints "feeling good" spleen size oncology this indication has a very low bar for efficacy yet is riddled with toxicity.
His SA article states;
"Geron's past disappointments and massive dilution without ever having advanced a drug past a Phase 2 trial doesn't inspire confidence when handicapping the company's ability to advance Imetelstat to market." true until they hit a best in class winner like Imet with CR's, PR's and EL's in MF
"Geron's one and only drug Imetelstat, while showing early promise, is currently under a FDA clinical hold for abnormal liver function tests." reversibility of liver abnormality tests placed ET & PV on clinical hold excluding MF, MDS, AML, and Blast Phase MF testing which was lifted from partial hold. The trials that are not held are Tefferi's MAYO CLIIC MF, Blast Phase MF, MDS and AML as well as a young patients with brain tumors trial.
"Imetelstat is years away from market - and that is only if it gets the FDA clinical hold lifted and makes it through multiple rigorous clinical trials." not with a Best Therapy Available designation for MF, Blast Phase MF, MDS and AML. Perhaps for PV & ET years away would be true.
"Incyte's Jakafi is the best available therapy for Myelofibrosis, offering much-needed relief and extended survival benefits to patients" Not if you ask people on Imetelstat trial study for the last 17 months with a complete remission and scarred bone marrow tissue healing.
"Jakafi is closing in on FDA approval for a second indication (polycythemia vera). PDUFA scheduled for December 5th. This additional indication could push Jakafi peak sales over $1B." and if the FDA doesn't rubber stamp their highly anticipated NDA filing application based on weak results, their SP will
keep gnawing on those wooden legs of INCY, it won't have any left to stand on. ;=3)
to quote Irish, it's become the "endless Phase I trial that was supposed to be over last March"...John is 17 months and counting on the longest phase1 trial ever
concrete jungle where dreams are made of,
There's nothing you can't do
Now you're in NY,
these streets will make you feel brand new
Big lights will inspire you,
lets hear it for NY, NY, NY
not sure where one gets their updated tute data from but Yahoo pegs it at 33%, FINVIZ@ 42%, NAS @ 48.2% State Street sold out of 5 million shares in June after the partial hold news release, net drop in tute ownership is about 7 million shares since June
well see how far Okarma gets with manufacturing stem cells. It's far more costly than throwing a placenta in a blender. The IPO ASTY & BTX still have a long way to go before feasibility is determined. IMET has scored on one front wrt to myeloproliferative disorders.
I've seen many other drugs listed on drug supply sites that actually don't exist. All you do is call the site and try to follow through with an order and you'll realize it's std. misleading advertising practise by many companies. China has dozens of such sites. Mecandoforu Meds
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
In the running since it's inception 9 years ago with 22 changes registered you would think they had collected enough LFT data to fill a library. Could be a sunrise surprise or a new moon gloom.
it's normally a summertime activity. Water levels usually start dropping by fall and then the pond freezes over. We just plug leaks here and there. The dam is built, a big Chinese built water pump just sucked $25Billion from the lake so we'll now need that global warming deluge to refill the pond. Bring it on.
Black the reason no one is discussing IMET's MedKoo listing is because it states on their site; "GRN163L This agent is not in stock, which MAY be available through custom synthesis" meaning although they list it they don't produce it but if it wasn't under patent and you really wanted it for a price they could probably quote you from one of their Shanghai black market pharma suppliers. Good luck with this as you could go directly head on with GERN & INCY with your order from MedKoo and bypass the management team you're so fond of.
08/29/2014 25,512,498 a 2.47% increase in one month average daily vol. 1,496,135 17.05 days to cover means they covered by Sept 15th last Monday when stock close was $ 2.38. We had some strange vol. trades last Friday 1mil shares at close spiking SP volume to 4million shares. Where these options being settled or just more shorts jumping on the bandwagon?