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.

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.

FDA advisors will also be voting on Fragmin, a blood thinner from the world's biggest drug maker, Pfizer Inc. (down $0.07 to $27.66, Charts) The drug is already on the market as an FDA-approved preventative for blood clots that form in the legs in patients undergoing hip replacement or abdominal surgery, or who are at risk for forming clots because their mobility is restricted from illness. New York-based Pfizer is trying to get Fragmin approved for an additional use, to reduce the recurrence of a common type of heart disease called symptomatic venous thromboembolism in cancer patients.

But the future of Pfizer is not riding on Fragmin. Pfizer reported $23.5 billion in sales in the first half of 2006, and the company is trying to beef up its pipeline with potential blockbusters - drugs totaling at least $1 billion in annual sales.

Fragmin's sales are so small that Pfizer would not break out the figures for this story, and it is unlikely that an additional indication would push Fragmin into blockbuster territory.

Abraxane, a drug from Los Angeles-based biotech Abraxis Bioscience (up $0.58 to $24.82, Charts), is already FDA-approved and on the market as an intravenous treatment for breast cancer in patients who failed chemotherapy or relapsed.

Sales jumped 23 percent in the first half of 2006 to $66 million, a substantial piece of the company's overall sales of $305 million in that period. The company estimates that Abraxane sales will jump up to $190 million this year.

Abraxis also wants to get Abraxane approved by the FDA as an additional early-stage treatment for breast cancer, meaning the drug would be added to other forms of treatment to boost effectiveness.

FDA advisers will be voting on what should be required of Abraxis to get its drug approved for the additional use. So while this vote is an important step for Abraxis, the stakes are not quite so high.

Clarification: An earlier version of this story did not adequately explain the indicated additional use of Fragmin. CNNMoney.com regrets the omission.

The analysts quoted in this story do not own stock in Genta, but Janney Montgomery Scott does make a market in the company and Rodman & Renshaw has done investment business for Genta.

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