We've come too far
To give up who we are,
So let's raise the bar
And our cups to the stars
We're up all night to get lucky
bringing GERN to the auction block perhaps. Maybe that's what this is all about. The FDA frowns on companies such as INCY that promote a useless comfort drug to inflate their bottom line or companies that skew data results for the same reason. GERN's ET & PV studies data has yet to be found. The MAYO trial was a success and who really knows who is pressuring who in this deal. It's like we are in a Russian federation with two heads running the company, one brown the other white. Add to that all the spin speculation and you have a vanilla mocha swirl dble scoop.
IMPORTANT TO NOTE in the same "COMFORT STUDY" release
"Jakafi can cause serious side effects including:
Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache"
All this doesn't sound very comforting to me.
they were quick to release this a week later;
"Jakafi is the first and only FDA-approved treatment for patients with intermediate or high-risk myelofibrosis
WILMINGTON, Del.--(BUSINESS WIRE)--July 28, 2014--
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food & Drug Administration (FDA) has approved supplemental labeling for Jakafi(R) (ruxolitinib) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information. The new overall survival information is based on three-year data from the two pivotal Phase III trials, COMFORT-I and II, and shows that at three years the probability of survival for patients treated with Jakafi in COMFORT-I was 70% and for those patients originally randomized to placebo it was 61%. In COMFORT-II, at three years the probability of survival for patients treated with Jakafi was 79% and for patients originally randomized to best available therapy (BAT) it was 59%"
well Black last year the SP started it's lofty accent on August 7 from $1.20 to $5.40($7.36 intraday) in Dec. We could have a repeat performance of a 400% gain which would convert to ? by your bonus paradigm. (maybe a bonus in excess of $2.3million)
I agree that all American CEO's are overpaid. In this space though it's the hedge funds MM creating most of the SP volatility. We are down over 30% from last month on no bad news and relative low volume. Other factors such as the INCY lobby that has just completed their "comfort" study to further promote a sub standard MF treatment to further reap financial headwinds in this space doesn't help. This based on known serious side effects of rux.
The following side effects are associated with ruxolitinib oral:
Common side effects of ruxolitinib oral:
Abnormal Liver Function Tests Severe
Decreased Blood Platelets Severe
Decreased Neutrophils a Type of White Blood Cell Severe
Urinary Tract Infection Less Severe
Dizzy Less Severe
Weight Gain Less Severe
Head Pain Less Severe
Gas Less Severe
Bruise Less Severe
High Cholesterol Less Severe
Infrequent side effects of ruxolitinib oral:
Rare side effects of ruxolitinib oral:
Progressive Disease in the White Matter of the Brain Severe
A Fungal Infection that Occurs Under Certain Circumstances Severe
Active Tuberculosis Severe
Ruxolitinib does not reverse bone marrow fibrosis or induce histologic or cytogenetic remissions. Imetelstat does with less toxicity
from an earlier discussion about Jakafi's LFT abnormalities (published by the MAYO) and anemia and thrombocytopenia toxicity issues has yet to sway the FDA from imposing a clinical hold on Rux). 80% of physicians polled suspected JAKAFI as an adverse event culprit.
Most common side effects for patients taking JAKAFI:
DEATH (106 patients)
ANAEMIA (30 patients)
FATIGUE (29 patients)
HOSPITALISATION (25 patients)
DYSPNOEA (25 patients)
HEADACHE (21 patients)
PLATELET COUNT DECREASED (20 patients)
PANCYTOPENIA (19 patients)
FALL (19 patients)
HAEMOGLOBIN DECREASED (17 patients)
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.
would make sense to overlap for patients currently being successfully treated. All that's missing is the new phase 2 start date.
working the old risk aversion angle are we? If as you say GERN should be trading at $4 for outstanding potential then it's a screaming buy down here at $2.40. Less downside risk than upside.
The last time I put my money in my mattress it got soaked in the beaver lodge when the water level in the pond rose.
Wgbox we were told updates at ASH. If last year was any indicator news was leaked out prior to ASH.
obviously ur no expert so stick to what you do know which is very little. The original intake group had severely advanced MF patients that had exhausted all other possible options. Nothing else worked for them. For IMET to get CI & CR from this group speaks highly of it's efficacy. Many of these patients had gone off of Jakafi as a failred therapy. If MAYO hand picked healthier patients from the get go results would have been far higher, however Teferri is into saving lives and gave these people another chance at a longer life.
IMET has far less side effects than INCY's Jakafi which offers no CR and relieves spleen swelling for several months till patients finally succumb to its side effects and choose to stop treatment or expire altogether. Hardly a comparative, yet INCY has FDA approval because there was nothing else around bfr IMETand has made billions on it.
E2 mentioned he was concerned about Teferri not being scheduled yet at the ASH, but until the FDA hold on IMET's clinical hold is lifted he's limited to what he can present other than updated data from the MF trials.
we'll need something more before ASH to keep the sharks at bay, otherwise they'll eat through the haul of this ship
not sure when he was scheduled last year, but he did blurt out some news on Imet bfr the conference, much to everyone's surprise. With all the politics & lobbying surrounding this potential blockbuster they've probably adapted a more reserved stance. If the MAYO wasn't behind IMET they would have never published IMET as one of their on going MF programs offered in their latest brochure.
Company CC on Aug 11 is to discuss "recent events" may be just for the Asterias shares, but could be for much bigger news yet to come.
Watch out for icebergs!