Didn't they have a pipeline they were working on at one time. Could a private company such as Trans Tech be the net benefactor of this latest action?
Volume as of late is looking like it was just bfr. the June 13 partial hold lift news. Hopefully it will be a repeat coming soon with a full lift. Mind you short interest was down then as well.
as in the MF trial patients were allowed to continue given they were benefitting by the drug. Some question as to whether CI or CR/CR was the cut of line.
material events "outside" of company trials are not obligatory to report? Or is that just the practise?
...would have remissions by Imetelstat effected these trials time lines? you would have thought any mareial event would have been reported by the company. Irish already pointed out IMET's MF 1ST is one of the longest running studies to date.(17+ months)
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