Only in a small biotech company with great potential.
The shedding of the BK proceedure opens the road from proof of concept to use in therapy.
For Biovest I expect an abbreviated version of the journey that Provenge took to approval. From May of 2007 to May of 2009 was an unnecessary delay for Provenge.However Biovest will have an easier path to the FDA BLA vote because of the rough road smoothed by Dendreon.
I can't address the pps but I see the near term future for ABPI/BVTI to be involved in the compilation and presentation of secondary data for the indolent NHL study and the preparation for submission of the BLA.
IMO the data for support of the BLA for BiovaxID will have been gathered and reviewed in the first first half of 2011. The preperation of the BLA submission including readying the production and storage facilities for FDA inspection, revision and approval will be ongoing.
IMO the BLA will be submitted in the second half of next year.Ihave my fingers crossed that it will be in time for a November meeting but delay seems to be the fate of Accentia/Biovest.
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