Genta, Inc (fka GNTAQ)

[garza]

Found this on the Google finance boards:

http://finance.google.com/group/google.finance.655996/browse_thread/thread/c35350b1299291d2

GNTA about to EXPLODE!!!

From: [e-mail] - view profile
Date: Thurs, Dec 25 2008 9:55 pm


-- FDA REGULATORY HISTORY OF GENASENSE IN CLL --

Please read the information below so that you can get a realistic, no
BS, understanding of where Genasense stands in its FDA approval
process and why its chances of being approved by the FDA are as good
right now as they have ever been before in the past, if not better.
This will hopefully allow you to understand why shares of GNTA stock
are extremely UNDER-VALUED right now and why you need to GET IN THE
GAME before it is too late!!

* December 29th, 2005 *
Genta Inc. files New Drug Application (NDA) for the use of Genasense
plus chemotherapy in patients with relapsed/refractory CLL.

* October 30th, 2006 *
FDA extends review period for Genasense NDA in CLL for 90 days to
January 29th, 2007.

* December 15th, 2006 *
FDA issues a non-approvable decision on NDA for Genasense in CLL

* April 4th, 2007 *
Genta Inc. appeals FDA decision on NDA for Genasense in CLL

* October 25, 2007 *
Genta Inc. completes appeal of FDA decision on NDA for Genasense in
CLL

* January 14th, 2008 *
FDA extends review of Genasense NDA appeal in CLL

* March 17th, 2008 *
FDA indicates that Genasense approval in CLL will require additional
confirmatory data. The Center for Drug Evaluation and Research (CDER)
recommends two alternatives for exploring the efficacy of Genasense
that could provide such confirmatory data. Genta Inc. plans to pursue
both of these options.

* June 6th, 2008 *
Genta Inc. submits NDA Ammendment to FDA for Genasense in CLL.
Submission based on increased 5-year survival data for responding
patients.

* July 14th, 2008 *
FDA accepts Genta Inc.’s Ammended NDA as complete response for
Genasense treatment of CLL. The FDA considers the response as a Class
2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date
of December 3rd, 2008.

* December 3rd, 2008 *
Genta Inc. receives complete response letter from FDA to its amended
NDA of Genasense in patients with CLL. In its letter, the Office of
Oncology Drug Products (OODP) indicated that they could not approve
the NDA in its present form and suggested the need for an additional
clinical study.

* December 11th, 2008 *
Genta Inc. files appeal of the FDA’s recent non-approval decision on
the amended NDA for Genasense in patients with CLL.

-- OTHER DUE DILLIGENCE POINTS TO CONSIDER --

* According to the Performance Goals contained within the Prescription
Drug User Fee Act (PDUFA),

“… the response to appeals of decisions will occur within 30
calendar days of the Center’s receipt of the
written appeal.”

The PDUFA’s performance goal has been set at 90%. This simply means
that their goal is to provide responses to NDA appeals within 30
calendar days of receiving the written appeals for at least 90% of its
appeal cases.

* If the FDA has any interest in meeting their PDUFA 30 day, 90%
performance goal, we should expect to see a response sometime within
the next 2 weeks. However, Genta Inc. submitted its previous initial
appeal on October 27th, 2007 and did not receive a response until
approximately 80 days later, on January 14th, 2008. Taking the
holiday season into consideration, it is likely that we won’t hear
anything from the FDA until the end of January 2009 or even beyond.

* Genasense is the very first drug of its kind to ever exist. It has
received Fast Track designation by the FDA in its approval process for
use in treating CLL, meaning that the indication represents an unmet
medical need. Fast Track designation enables the Company to submit the
NDA on a "rolling" basis as specific sections are completed.

Genasense is STILL rolling along with its NDA approval process. Its
coming and you need to get in the game FAST before you get run over.
At less than $.01 a share, GNTA is poised to make you hundreds of
thousands of dollars. Its going to get up to at least $.50 - $1.50
before we ever hear anything from the FDA.

Buy GNTA. Get in you guys.