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GNTA.OB...Sector: Healthcare...Industry: Biotechnology & Drugs

Started by ours, May 09, 2005, 11:33:00 AM

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joet

Genta seems optimistic... being a technical trader i wish that i understood the FDA approval process...  I will probably hold my position through the news and hope for the best... If it gets a run on Tuesday I may sell half...  the technicals do not seem to mean anything here but it is still above the double bottom support of 1.28...  if that breaks down on Tuesday may sell half as well
tough call here
GLTY
Cheers Joe

D&Data

have on this stock tomorrow....there will have a lot activity !!

""If the FDA experts recommend Genasense for approval on Sept. 6, and if the agency approves it in late October, Genta's stock could jump and the new product could bring in tens of millions of dollars in annual sales, according to Brian Rye, analyst for Janney Montgomery Scott.""

????
Tomorrow will show us ...

Id.


la-onda

strange chart for the last days.......

A tale of 3 drugs - and 1 biotech
Future of biotech Genta could be determined by vote of experts advising the FDA.
By Aaron Smith, CNNMoney.com staff writer
August 31 2006: 10:20 AM EDT

NEW YORK (CNNMoney.com) -- Experts advising federal regulators will case votes next week that could make or break a small biotech specializing in cancer drugs, but the vote may not mean that much to the world's biggest drugmaker, Pfizer.

Genta Inc. (up $0.06 to $1.86, Charts), a biotech based in Berkeley Heights, N.J., is hoping that the cancer drug experts recommend its experimental leukemia treatment Genasense for approval by the Food and Drug Administration. The advisors' vote is a non-binding suggestion to the agency - not a final decision - but it is important because the FDA usually follows the advice of its advisory panels.
fda_food_drug_admin.03.gif

If the FDA experts recommend Genasense for approval on Sept. 6, and if the agency approves it in late October, Genta's stock could jump and the new product could bring in tens of millions of dollars in annual sales, according to Brian Rye, analyst for Janney Montgomery Scott.

While that's modest for a new drug, it could be crucial to a small biotech like Genta.

If Genasense is approved, it would be used in combination with chemotherapy as a treatment for a type of cancer that causes bone marrow failure and can spread. But the regulatory process has not gone smoothly for Genasense, so Rye is cautious about the biotech's prospects going forward.

"To be sure, an investment in Genta is not for the faint of heart, as all eyes are focused squarely on a single drug, Genasense," he wrote in a note earlier this month.

Rye wrote that Genta stock price is trading for less than $2 a share, making it "appropriate only for speculative accounts with a high tolerance for risk and price volatility."

The analyst rates the biotech a "neutral," even though he estimates that Genasense annual sales could exceed $100 million by 2008 and the stock price could jump to $3 a share.

While $100 million is a paltry sum for the largest drug companies, it would be a major windfall to Genta, which reported $446,000 in sales during the first half of 2006 from its single product, Ganite, an injectable drug to treat high calcium levels in the blood related to some forms of cancer.

Rye wrote that Genta "still needs to prove that it can successfully navigate the regulatory waters," noting that Genasense received an unfavorable vote from cancer drug advisers for a separate indication - treatment of malignant melanoma - in 2004.

"If these efforts are unsuccessful, the company's very ability to survive beyond the next year or so can be called into question," wrote Rye.

Ren Benjamin, analyst for Rodman & Renshaw, also rates Genta as a "neutral." His advice for investors is: "Don't get into the stock before the [panel] meeting."

Benjamin said a negative vote could drive the stock below 50 cents a share, noting that Genta was valued at $8 a share before its unfavorable vote in 2004.

"It's something that investors should watch, and watch from the sidelines, and learn from," he said in a phone interview. "If [the vote] is positive, investors may miss the initial bump up in valuation, but they will have the added confidence, and plenty of time, to ride the stock further."

A company spokesman was not immediately available to comment on Genta's viability based on the success of Genasense.

D&Data

#108
ooops...down big 50%....and nothing has been decided ! but with waiting....

WASHINGTON, Sept 5 (Reuters) - U.S. Food and Drug Administration staff on Tuesday questioned the benefits of Genta Inc.'s (GNTA.O: Quote, Profile, Research) experimental drug, Genasense, for patients with a type of blood cancer.

In a summary prepared for an advisory panel that meets Wednesday, the FDA staff said 10 percent more patients with chronic lymphocytic leukemia responded to chemotherapy when Genasense was added, but the difference "is of questionable clinical significance."

Adding Genasense also "appears to add to the toxicity of the treatment," the FDA staff said.

© Reuters 2006. All Rights

But it's not finished...verdict tomorrow :-X

D&Data

again down Big

FDA Panel Votes Against Leukemia Drug
Wednesday September 6, 2:48 pm ET 
FDA Panel of Cancer Drug Experts Says Leukemia Drug Shouldn't Be Approved


WASHINGTON (AP) -- A proposed leukemia drug should not receive federal approval, government advisers recommended Wednesday.
Genasense is proposed to be given along with two other medications to patients with the most common adult form of the blood cancer, according to manufacturer Genta Inc. But a Food and Drug Administration panel of cancer drug experts recommended against approval in a 7-3 vote.

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The FDA isn't required to follow the advice of its advisory committees, but usually does. The Berkeley Heights, N.J. company said it expects to hear from the FDA by Oct. 29.

"We remain committed to the development of this agent and will continue working with FDA regarding their review of this application," Dr. Raymond P. Warrell Jr., Genta's chief executive officer, said in a statement.

Earlier, FDA reviewers said that more leukemia patients responded to chemotherapy when the Genasense is added to their treatment mix, but cautioned that the overall difference is of "questionable clinical significance." Adding the drug also appears to increase the toxicity of the treatment, the FDA said.

Genta previously sought FDA approval for Genasense in treating advanced melanoma. In 2004, an outside panel of FDA experts voted against recommending the drug be approved for that use. The company then withdrew that application for the drug, also known as oblimersen sodium.



---->  :(

Melf Elf

Quote from: IdFix on September 06, 2006, 04:42:12 PM
again down Big

---->  :(


IdFix,

I appreciate the fact that you've shown up on a trade when it's down big, like this one.  Normally, posters "disappear," on these disater trades, and only show up in folders on days when the stock is "UP 10% today!!"

Good for you.  Applause.

D&Data

#111
Big volumes now...: about 24 000 000 traded shares today

http://finance.yahoo.com/q/hp?s=GNTA


pps really low ... traded between 0.47 - 0.52...

http://finance.yahoo.com/charts#chart1:symbol=gnta;range=5d;indicator=volume;charttype=line;crosshair=on;logscale=on;source=

Stabilisation around .5 ?....

And yes...sorry Melf Elf, the day after my last message, GNTA give us a 20% profit before going down...
but, by now...for quick profits....what do you think of it ? Today, 6% if not bought @ .47

IdFix


D&Data

goooo !

up 30 % ;D

Final Report of Genasense Phase 3 Trial in Melanoma Published in Journal of Clinical Oncology

....yeah...good !

ID.

D&Data

up 17 % now  on strong volume again....

--> http://finance.yahoo.com/q?s=gnta

hè hèèè  ;)

D&Data

#114
GNTA pm 0.86$ ...up  again   :-X

News...Independent Analysis of EORTC Trial Confirms Survival Impact of Biomarker Identified in Phase 3 Trial of Genasense(R) in Melanoma

http://finance.yahoo.com/q?s=gnta

But ...that has been so explosive these days...that we could see a little implosion today...

Id...........


D&Data

#115
this bomb is now @ .96 $  :o

100  % return profit in one week

Id....

D&Data


ScottishTrader

#117
Hey IdFix

You still in this one???  or got back in again?  Have been holding a bit from last week at .80, and now the placement is closed (also at .80) it looks like it is getting a bit of momentum again today.

From the breakdown last week after they made the stock offering, i see a symmetric triangle consolidation on the 30 min chart that has just broken to the upside.  The target of this triangle measures to .95.

I know this one is very risky, but I am willing to hold out for a move to 1.00.  at least for now...

D&Data

more than 17 % PM.... :o

Genta Receives Special Protocol Assessment from FDA for Randomized Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic Leukemia

this baby will fly again today

Id...

setravis

#119
All threads on GNTA have been merged.
Good trading to all.....make some $$$  ;)
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis