on low level liver function abnormalities reversals? He didn't answer that question at the CC this morning as he was surprised that the FDA would even request such data at this late juncture.
It's a complete scam by the FDA's part. We need a MAYO BUYERS CLUB set up to get around their political wrangle. Persistent low level abnormalities can be caused by sitting behind a desk at the FDA eating donuts and drinking coffee all day.
...the low grade persistent abnormalities were not understood to be caused by the drug at this point. The FDA was interested in the reverse of any liver function abnormalities in grade 1-4 data. A review of all the data which may be difficult given the time lapse since all those studies were finished may present a problem. Chippy was obviously taken back by this request at this point. No one asked him what was planned to be presented at the CC after market today as was previously planned had they not received the call from FDA. The Mayo's data will be presented at ASH. Maybe INCYTE moves in for a cheap buyout now. FDA reverses their hold and imetelstat goes on to become the next wonder cancer cure without any retailers making a cent.
can the FDA recall alcohol. After seeing Buyer's Club and witnessing widespread politics surrounding FDA approval and BARDA grants I believe that this entire system is need of a major overhall.
JAK2 had some even greater concerns over brain lesions that were never cause for FDA's concern. And as in the earlier cancer studies imetelstat levels where as high if not higher without triggering an FDA hold. The drug was deemed as ineffective on solid tumors. Here imetelstat gets a breakthrough possible indication competing with a multi $Bil company and the FDA comes crashing down on it. MAYO would have been aware of serious liver functions much earlier than just hrs bfr. GERN was to announce expanded phase 2 trials.
Why wasn't an FDA hold placed on the imetelstat clinical studies earlier...they've had 2 years of safety data now from 100's of clinical patients? This rings more of politics than efficacy. Why was JAK2 not put on hold for possible brain lesions in patients?
The FDA has two years of data on Imetelstat collected and only now comes out with a hold because of possible liver functions toxicity. Doesn't make sense that it would have been undetected in all previous trials with larger number of patients and studies progressed as manageable and now is placed on hold. The timing of this is highly suspect. Is this Incyte's doing? Not sure if Chippy can turn this around but I'm having serious doubts. He owns no shares.
They have only just been notified by FDA yesterday afternoon and I was thinking on loading more...
"The clinical hold affects the remaining eight patients in the company's Phase 2 study in essential thrombocythemia or polycythemia vera and the remaining two patients in the company's Phase 2 study in multiple myeloma." This affects 10 patients. And FDA concerns have yet to be discussed.
more smelly than fishy.
all the previous imetelstat studies had no mention of this as a toxicity concern. Why would the FDA bring this up now? Is this part of the JAK2 cartel?
I've been big on pot plays ever since last year. It helped me through the winter shacked up in that small lodge with Brando. Kitty came by to see what was up. TRSX was taken out by that developer from CBST and Mrs Alfalski signed over the sale of her lovely home in Pugwash Station under the influence of pot laced pizza from the VTUS go daddy shop. Life just seems so complicated sometimes.
I have new reading glasses whilst waiting fur the drops. (;8=3)
This is Wall Street. It's run by the devil himself...notice the SP going up after the CEO refused to save the kids life.
had to debunk all the FUD on the windshield
.....the trend here is that Dalbavancin has been de-risked as an FDA candidate given the new requirements and the accelerated approval process change for new antibiotics.
beavertail_splash • Mar 6, 2014 10:49 AM
efficacy of penicillinase-resistant penicillins, vancomycin and teicoplanin are now heavily challenged by bacteria resistance to these drugs. With great pharmacokinetics & tolerability properties Dalbavancin, a weekly IV antibiotic has undergone several modifications of the parent compound making it another potential addition to fighting MRSA bacteria. As good as linezolid gets the FDA nod nowadays. Bfr it had to be better than. $20 here we come!
he's related to the Grim Reaper who keeps him in a steady supply of experimental cadavers.
you make it sound as though imetelstat caused the death. It contributed to his thrombocytopenia low platelet count which he was already suffering from but wasn't the direct cause of it.
To refresh your memory;
"At a median f/u of 3.2 months, 16 (89%) patients remain on treatment; the two discontinuations were from unrelated death and disease progression. In cohort A, there were no grade-4 treatment-related adverse events; grade-3 events were limited to thrombocytopenia in 27% and anemia in 9%. In cohort B, two (29%) patients experienced grade-4 thrombocytopenia; grade-3 events were limited to thrombocytopenia, neutropenia and anemia in one patient each. Dose reduction was necessary in only two (11%) patients because of grade 3 or 4 myelosuppression"
One patent of the two that died had pre-existing thrombocytopenia (low platelets) and was given a dose of Imetelstat who subsequently developed intracranial hemorrhage when his platelet counts dropped even further. In other words the one death in question had to do with an unrelated pre-existing condition (low platelet count) and the 'good' safety profile of Imetelstat is still in tact.