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Lymphoma and Pets
BiovaxID: On the Trail of the Follicular Lymphoma Vaccine (Part 1)
Shortly after the meeting, Biovest issued a press release about the meeting, details of which they also included in an SEC filing. The FDA dealt the company a blow in their bid to gain regulatory approval for BiovaxID in the US by requiring the company to run another Phase III confirmatory trial.
The company is seeing results with their efforts to bring this therapeutic vaccine to Canada and to the European Union. Despite the recent tendency of the FDA's Office of Oncology Drug Products to rubber-stamp the overwhelming majority of cancer drugs that make their way to Washington, they opted to require more from Biovest than we've seen them require from other companies and in many cases the sub-standard treatments those other companies presented to the agency.
BiovaxID offers the follicular lymphoma patient an enormous, long-term survival and quality of life benefit as consolidation therapy following induction treatment, the kind of benefit not seen before in lymphoma.
In other words, the problem here is not the product; the problem, I believe, is in the myopic vision of regulators at the FDA.
On The Trail
Therefore, in this multi-part series "BiovaxID: On the Trail of the Follicular Lymphoma Vaccine", I'll look at the issue from a variety of angles:
-- I'll look at the FDA's recent history of approving cancer treatments.
-- I'll look at existing trial data for BiovaxID.
-- I'll talk with the principles at Biovest, including their CEO and their Chief Science Officer, to learn more about the science and the benefits of BiovaxID.
-- I'll talk with two of the chief clinical investigators of BiovaxID, Dr. Larry Kwak, Chairman, Department of Lymphoma/Myeloma at MD Anderson in Houston, and Dr. Eduardo Sotomayor, who holds the Susan and John Sykes Endowed Chair in Hematologic Malignancies at Moffitt Cancer Center in Florida.
-- And I'll also (I hope) be speaking with one or more of the patients who participated in the clinical trials for BiovaxID to find out about their experiences.
When finished I hope to have presented a solid explanation of how this lymphoma vaccine can improve the daily lives of patients with follicular lymphoma, and even mantle cell lymphoma, in a language all of us can understand.