The understanding mechanisms of action so far as trial biomarkers being identified in myeloproliferative neoplasms are telomere length. ASH had discussed other possible genetic markers that could aid the development of predictive genetic tests that could maximize drug efficacy and minimize drug toxicity.
As to response durability, efficacy is being measured in continued PR's & CR's from the MF 1ST trial (as Irish noted NEVER ENDING 1ST phase trial)
we share your frustration Irish not knowing the final pathway going fwd. on this trial. Phase 2 for MF has been dragged on beyond respectability for all parties concerned. Maybe it's time for another petition.
Hay, so what are you implying, that the FDA is about to announce some extremely bad news? I remember the incidence of the option play back in March just days bfr. the halt was announced. Someone made off with a few million on 5 cent puts. Short interest declined until the partial hold was lifted in June but has gone back up...haven't studied the options as of late. But as E2W points out there is no funny business behind the scenes...all is but a reflection off the pond feeding into Hickey Dickey Creek.
BTX owns 80% of ASTY and they're down too. Little volume, price easily gamed.
there you have it....we all know who's behind this assault on IMET and GERN's SP. It can only be challenged as Tefferi states with scientific "facts". And it's a fact that ruxolitinib is a drug not only with major safety concerns that the FDA seems to be ignoring but it does very little in treating the disease and in fact may pose a LT greater risk than not being treated with it. No remissions mean patients end up dying from the disease.
the third prong...after all the devil wants his dues would be partnering up with a strong armed pharma capable of swaying this obviously bent and two sided hold by the FDA to be lfted.
Stubs....take a look at last year's price movement just bfr the $7.36 run up to ASH. Last year GERN closed @ $ 1.79 on Sept 11/13. This year @ $2.46. There is much more longer term trial data now supporting continuing CR's & PR's in MF and possible other major indications for the drug in AML, MDS & in other drug combos. What's not to like? GERN could easily see a 3 bagger with the hold lifted. More with other indications data. The FDA's bladder is full and they have to release their hold soon or things will start leaking.
E2....they finally got to you too eh? ;=3I
I just read this Irish...must have missed it in the thread earlier although responded to oligodendrocyteprecursorcells's post (see why he rarely posts...if it were me I'd never remember how to spell my name)
We are all rooting for John to become IMET's first :"CURED" patient. Complete remission although miraculous in itself, a cured patient is a paradigm shift wrt this oncology treatment.
How can this science be any further delayed? As the MAYO Clinic has already stated regarding Imetelstat. "We have seen some complete responses (tantamount to a cure), which is almost unheard of in this disease"
thanx for bringing this up Rokky. Clearly the FDA's advisory committee process is corrupted by conflict of interest in it's members
E2W although "lobbyists" may not directly sit on review committees there are definitely questionable biases of members that could easily be influenced by such lobbyists. Just look at the MPN forum's summer publication.
From MPN website (Incyte is a sponsor and those that provided content receive funds from them):
"We now have assurances of privacy and an arm’s length relationship with sponsor Incyte"
"Guiding us in this effort are our personal hematologists and trusted MPN specialists. Doctors Ruben Mesa, Claire Harrison, Serge Verstovsek – all featured in this Summer issue of the Forum — are workers in the tangled obscure vineyard of MPN. They are our allies and worthy of trust and respect.”
As principal investigators into new drugs, however, they are also beneficiaries of funds from Novartis/ Incyte and other drug companies. looks to me the've been picking a lot of sour grapes
Imetelstat offers remissions and yet they were omitted from MPN's summer publication. Why?
No stretch to see how easily the same lobby could influence the FDA
Maybe they don't sit directly on the review panels but they certainly influence peddle their cause on the FDA. All you have to do is Google " FDA influenced by lobbyists" and read over 13mil results on the topic....ranging from "NY times editorial-FDA admits lobbyists influenced knee device approval, PBS Frontline special on how FDA budgets are determined by the lobbyists, $700 million in lobbying buys significant access @ the FDA"...........and so on.
The problem's far more pervasive than any scientific article would be willing to challenge. The FDA's internal dissent over Menaflex shows how political and industry pressure can actually influence scientific conclusions. The pharmaceutical industry wields enormous influence over the the annual budget of the U.S. FDA, with the help of staggering profits and 1,100-plus paid lobbyists.
It doesn't take too much to see where such influence peddling from a competitor could impact their decision when it comes to a small start up company with a new drug showing complete remissions.in cancer therapy
regardless of how much time off I take to floss my front teeth remain as yellow as a sapsucker's belly
just too self conscious to laugh in public I guess
haven't you heard of drug company lobbyists that sit on the review committees of the FDA panels that exert pressure on the FDA's decisions? INCY being the big FDA approved drug in this space exerts a lot of its weight around the FDA. That is why it may be important for GERN to team up with a larger pharma that can help counter this imbalance.
Pebble Beach is exceptionally nice to play this time of year. The last time I was there I started chewing down an ugly lone Cypress growing on some rocks. Some golfers started throwing golf balls at me so I had to leave. Beautiful scenery but very rude players. I guess it comes with the turf.
Hay two great points you've made and have been discussed at length. An elderly MF patient with advanced hep C complications dies and the FDA slaps down a clinical hold on all the Imet trials going fwd. except for MF First which was partially on hold and then taken off but yet MF Phase two cannot continue till the complete hold is lifted. This has got to be the most convoluted decision and reasoning I have seen coming from the FDA. If the data from the ET & MDS trials was "incomplete" well then it stands to reason that trial would be halted, until reversal data is submitted and satisfies the FDA but why penalize the company & shareholders with a complete hold when the MF trial was acceptable to the FDA to release the partial hold on the MF IND? I still question how that patient was allowed in on the trial I the first place given the certainty of his poor prognosis. This factor was not enough reason for the FDA to launch a complete clinical hold.
"Phase 2: Establishing the efficacy of the drug, usually against a placebo" like Jakafi
wouldn't that be a novel trial study ...IMET could move directly past go and collect $200 under BATD in one trial.
Data for ET trial will be submitted end of year. Can't see why the FDA can't approve MF phase II to go ahead based on MAYO MF Phase I data submissions already approved and lifted . Obviously other studies appear to be moving on.