FDA Grants Orphan Drug Status for Personalized Cancer Vaccine, BiovaxID®, Targeting Mantle Cell Lymphoma
Biovest International, Inc. (OTCQB: “BVTI”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.
With FDA Orphan Drug Status granted for this second indication, Biovest gains seven-years of market exclusivity for BiovaxID upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.
http://articles.moneycentral.msn.com/news/article.aspx?Feed=BW&Date=20100726&ID=11742626&Symbol=BVTI
What does this mean?
--------------
Kruser,
I own 1500 shares of BVTI. When they "emerge from bankrupcy" these stocks aren't going to become worthless, are they?
---