You'd better think twice, after today's warning...
This will be fun to watch!
And the tanking will continue after hours...
Where are the bagholders who bought above 1.5?
I told you boys that this POS would be closing in the 1.5 - 1.55 range, but the little Matty is a basher, right?
Keep wishing rather than open your eyes... you have no much time left...
Bid at 1.38... back to where it all started...
Hey boys and girls... if you bought today at 1.9, don't worry... join the sock's club and ask for a SEC investigation... while shorts and hedgies party! What a hell of a day!!!
Thank you again Dr. Worrell... many won't ever be many times to thank you all the support....
Now bring us that PIPE... after hours would be great... but we can wait until tomorrow, after market close, if you think that's better...
Iam going through this with ENCY and they have two approval letters,still waiting for an out right approval.Is it a possiblity that a approval letter will be the same for this GNTA. Try having two BIO waiting for out right approvals.
anyone know the percentages for sept 6th approval? Want to gamble? this is the stock to do it with. will either go to 2.50 on wed/thursday or drop below a buck. Not hearing enough feedback on the drugs effectiveness. Sooo tempting to buy lots and yet caution is my middle name. Probably just by a 1000 shares, here and there, depending on the trend. Good luck to everyone. A hit would be could for more than just money.
Look at it from the other perspective: how can it not be approved? The only problem with the drug was that it didn't succeed in its prior poorly designed study for melanoma.
But now, being tested for a completely different form of cancer, Genasense demonstrated safety and efficacy. Why would ODAC reject it?
This is not the 50/50 gamble that many believe it to be. I believe it's virtually certain that ODAC will like Genasense (*) and that the FDA will approve this drug.
* ODAC is supposedly critical of all drugs it reviews, so even if it's moderately critical, that still bodes well for an FDA approval.
>>Thank you again Dr. Worrell... many won't ever be many times to thank you all the support....<<
Beautifully said as always Matt. Please start typing in your native language. If anyone is interested, they can hire a translator.
"many won't ever be many times to thank you all the support"
Yeah, he's lost it. I guess spending 22 hours a day typing on the message board finally got to him. Caffeine and speed will only get you so far, before the big crash.
Please read this link.
GNTA application depend on this study for approval. FDA will look at efficacy and toxicity of genasense to make decision. For efficacy, 19 patients in GNTA achieved a CR (11) or nPR (8) while only 8 patients in chemotherapy achieved a CR(3) or a nPR(5).This mean more than double the survival rate for chemotherapy. As for toxicity, check the following table
Neutropenia 22 19% 28 24%
Thrombocytopenia 38 33% 23 20%
Anemia 17 17% 17 17
the high percentage for low platelet count in GNTA group can be explained by their short life span (9-11 days). From this we can say that Genasense will work very well in cancer cells that have short half life. Mortality occured after 30 days from the last treatment in 9 patients treated with Genasense/Flu/Cy and 5 patients treated with Flu/Cy alone (P=N.S.). The excess in mortality was due to fatal disease progression (5 in the Genasense/Flu/Cy group vs. 1 in the Flu/Cy group).
Base on this study I see that Genasense did meet the primary end point (double survival rate)and secondary end points (toxicity the same as chemotherapy). I don't see any reasons why this drug will be rejected
The Accelerated Drug Approval was started in 1992.
All drugs meeting the primary end point have been approved. For sure 100%.
According to an FDA agreed upon double blind review, genasense met the primary end point.
And BIg, has already posted the article that says genasense does not increase toxicity when added to F+C.
Good Luck BIg