Update: Biovest Aims For BLA, Not NDA (OTC:BVTI)
Today, on 9/22/09, StocksHaven Investments had the opportunity of speaking to the Investor Relations representative at Biovest International Inc., Douglas W. Calder regarding the recent profile we conducted. A few minor erroneous details were present, and thus we are issuing a company verified update to clarify these issues.
The first problem at hand was that we mentioned it would be a new drug application, however, it is in fact a biologic license application or, for short BLA. So what is a BLA? A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. Essentially, it is a formal application analogous to a New Drug Application, but for biotechnology-derived pharmaceuticals (for example, complex, large molecules).
Moreover, they are in fact expecting to have a face-to-face meeting with the FDA with regards to BiovaxID sometime in Q1 of 2010, afterwhich depending on the outcome, a BLA submission could follow shortly thereafter. Currently, Biovest is preparing an informational package for the FDA in order to share data on BiovaxID, and a number of other items, such as the manufacturing facility in Miniapolis Minnesota, analysis ongoing with the clinical studies related to immune response, mechanisms of action involving b-cells, t-cells, or perhaps combination of both. Douglas went on to state that, data points the FDA wants to see include the possibility of other predictors that can indicate a more likely outcome of success for the patient. During the meeting, Biovest will also discuss the possibilities of an accelerated approval process for BiovaxID.
Communication with the FDA is ongoing, and Biovest is paying close attention to the draft guidance issued for companies seeking approval with cancer vaccines which are unique to patients, and as well the section for granting of accelerated approval process.
On an ending note, it is important to keep into consideration that the company is under Chapter 11, thus there always exists the unlikely scenario that the current common shares may be cancelled.
Disclosure: Short position in BVTI
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