Send this in a letter to them...they don't use computers there. Make sure nothing happens to the postman en route or we could be in for another delay..
Frankly, my dear, I don't give a damn! All you need now is a divorce and your dreams of the Ashley can come true
Why wouldn't the company have immediate access if not available data on hand instead of having to work angles to obtain it?
I was thinking that maybe their motivation for the data request prior to any large scale testing but why put a hold on the drug in its current trials? That would lack integrity on their part knowing full well what such a measure would have on the companies market value. Incyte experienced some rather serious side effects amongst users (brain lesions) and yet the FDA never held up their drug under OTA designation.
If Incyte were behind the games played here no one will ever know by suing the company. You'll have to go to the hedge funds for that revelation. As to being ambivalent twds these ambulance chasers, this is America where everyone is dressed in a law suit.
Here come the ambulance chasers. Same law firm tried to launch a class action against GERN in Dec. 24 2010 for securities violations. Nothing heard from since.
The FDA has not stopped imetelstat yet , they've just placed a hold on it pending data submission which is already on file...somewhere.
FDA certainly handled this hold unprofessionally. Why not call GERN with their concerns and give them a timeline for more data if required rather than effectively stopping treatment for a total of 10 patients who maybe served better by continued treatment not to mention the effect of bad press.
I'm feeling better about the earlier PO Chippy exercised. He was able to sell the entire offer at above current pricing and increasing the bottom line to help ride out any such curve balls thrown at GERN by the FDA.
How does the FDA screw up on such a binary causing event, especially so late in the trials. Well if they did screw up then obviously they would release the hold but given the political overtones surrounding this hold my guess is GERN will need much more clout with them down the road. If I were a large pharma with clout this would be an opportune time to sweep in with some sort of offer/partnership. Given the injury to SP most would be in fav.of a deal to restore shareholder equity. I wouldn't be happy but this always happens to retail. Wonder if any of the big boys sold out prior to today's morning announcement?
Chip even said the certified FDA letter still needs to arrive. Just in time for April fools day.
set up a MAYO BUYERS CLUB in Canada....now that's a possible solution. Canada recently signed a free trade deal with Europe so they're no longer behoved to the political shackles of the FDA.
that's what I thought ...instead the FDA puts a HOLD wanting all reversible low grade persistent abnormalities data indications. I said that it probably came from sitting behind a desk at the FDA eating donuts and drinking coffee. Like VTUS it's a screaming buy. Unlike VEN 307, Imetelstat has given trial patients CR
....listening to Chippy speak this morning he sounded equally astounded by the FDA's request. Not sure what recourse the company has at this point but a partnership with a biggy pharma might help with clout at the FDA which is where this looks like it might be heading.
easy to figure it out. This stock has been heavily manipulated in trading all along. It's lead drug was about to launch a phase 2 expansion program and the FDA all of a sudden puts a hold on further development. All fingers point to one other player in this space.