#1 ...very unusual options activity taking place 2 days prior to the news release (that would be a day before Scarlet received the FDA call on Monday).
#2...the fact that this particular hold wasn't fore seen at all by management and seemed to catch them blind sided. Scarlet was lost for words as to why the FDA was asking for liver function reversal data so late in the trial when many of the subject were no longer in the MM study. I believe 10 remained. And given the fact that the FDA would have approved the clinical testing in the first place, why wasn't this inadequacy requested before?
#3...the fact that the MAYO clinical trials stopped any new intakes and would continue with those already in the study. We were led to believe from the company's CC they would launch multi centred phase 2 MF testing at various locations as soon as approved by the FDA." We expect to initiate a Geron-sponsored multi-center, Phase 2 clinical trial of imetelstat in patients with MF in the first half of 2014"
#4...the fact that INCYTE could lose a big part of their current JAK2 market if and when Imetelstat gets approval. When $BIL's are at stake the game can get very nasty.
#5...the fact that the secondary for the full 28 mil shares @$4.00 was completed a week bfr. the FDA hold was announced seems too coincidental.
#6...the fact that you're beginning to sound like Putin giving the world proof of his democratically elected annexation of Crimea when in fact it was an orchestrated set up.
#7...the fact that Dr. Tefferi was trashing JAK2 inhibitors in a MF medical review publication not too long ago and yet when asked about the current data Scarlett referred to the next coming ASH conference for disclosure. What was that all about.
...what about GERN? If we get this hold cleared up it's all the way to the races, a triple is doable in short order. You remind me of the mortician hanging around the morgue with his business cards. Most that hadn't sold out on Wednesday believe the hold will be lifted.
....more and more this is pointing to some insider influence backed by the JAK lobby. Investors were blindsided, the company was blindsided and the FDA acted recklessly on this recent hold. Immediate lives were not threatened and as the MAYO Clinic trial is still on going, the entire directive was a best confusing and at worst a $300mil mishap brought on by the FDA.
Well we have letters to the company & FDA. Now it's your turn to send one off to the SEC to further investigate this obvious "insider" based trade. Did it come from someone connected to the JAK2 lobby, FDA or Menlo Golf & Country Club? Short of being John Edward this investor had more than psychic powers. Although I was planning on selling out that Wed not wanting to hold over an earnings report and sensing technicals were throwing out a potential large move either way. I'd never play options for precisely the reason we have witnessed, unless of course I had insider knowledge and was confident of the outcome.
The FDA; decision to request a hold on 10 patients currently in MM & ET studies, essentially cost a $300m market haircut. Had they requested the data before any on going studies or MF phase 2 expansion studies this adverse effect could have been avoided. It was reckless on the FDA's part. It's not like a final approval decision where all the data has been submitted and made public. We as the investing public as was the company should have had some considerations in this request & hold. My point was that it was reckless.
....it was more like that sink hole in Vagina Saskatchewan that swallowed the city works truck on Friday.
Hedge funds issued 48 mil worth of calls above $2. That was an unprecedented number. Most were in the money till Wed. premarket. I fthey can keepSP below $2 till options expiry they stand to make $120mil, more than GERN's latest PO
hope this vote was't like the one in Crimea.
"if you think that the FDA screwed up vote yes or if you think that the Incyte lobby got to the FDA vote yes"
...well actually it's butt cream that recently took a fumble cause there were no toxicity issues that could put you on a gerny but rather no issues showing improvement over face cream. The trial was geared to morbidly overweight attention seekers that deliberately skewed reporting results so they could have more clinicians checking out their well you know butt.
Me I was lucky to get out bfr the 307 ambulance drove buy but had no idea it was heading twds GERN. I'm on life support iron lung I managed to fashion out of an old rusty muffler salvaged from that $300 mil car crash over in GERN pond. If it wasn't fur the liver stew I'm being fed daily, antibiotics and some medical MJ I'd be nothing more than a bald beaver pelt.
they zapped poor father beaver to death. A mistaken overdose of radiation, and he died within hrs. Never lived to see his grand pups. I've gotten over it but I agree the FDA has approved a lot of potentially dangerous procedures and drugs. This whole GERNY thing has given me a big headache. I think I'll just take a paw full of Tylenol washed down with a scotch chaser.
This study to the best of our knowledge this is still on going although new intake has been stopped. Hope the good Mayo Clinic Tea-fairy has some unconjugated bilirubin data he can share to appease the bean counters at the FDA who put imet on hold for ET. I thought ET was an extra terrestrial? Why would an ET want to hijack a trial? A plane maybe but a trial?
So you're a bean counter. This issue involves unconjugated bilirubin, much more complex.
I always had difficulty with unconjugated bilirubin in grammar school myself. How's any 5th grader suppose to know the answer without the data? Scarlett was even taken back.
"Reported publicly in March 2013, we have observed persistent LFT abnormalities in the ET trail. At least one abnormal LFT has been observed in all of the patients in this trial. The majority were Grade 1 or Grade 2 elevations in ALT or AST. Reversible Grade 2 to Grade 3 elevations in ALT with Grade 1 or Grade 2 elevations in AST were observed within a few weeks of starting Imetelstat in some patients" ...maybe the FDA needs a 5th grader to interpret the data?
how could he make a quick profit when the price fluctuated between $1.30 15 minutes into open on Tuesday to a high of $1.90 the next day closing @ $1.83 today. If he was lucky enough to catch the spike a 7 cent profit was realized. Whippy cushion profits.
Tuesdays downward gap was premarket. The level wasn't all over the map like one would expect. The day traded pretty well level @$1.80 after the 9:30am dip down to $1.30 within the first 20 minutes.
My suspicion still lies with the hedge funds that issued options totalling a whopping 56million shares x $3 =$166 million dollars if U were on the right side of the calls and puts trade. 48mil calls above $2, 8mil puts above $2
Any fund issuing the calls will be paid at least 48-8=40x $3=$120 million. That's more than Scarlet raised with the PO. Perhaps it's the hedge funds that orchestrated this hit job and paid off the FDA.