Biotech Values

[DewDiligence]

>ALTU – Based on a positive FDA response to Altus’ pre-NDA meeting submission material, Altus and the FDA have agreed that the Trizytek clinical development program supports submission of a license application for Trizytek.<

As a seasoned biotech investor, you ought to now that this kind of statement in biotech company’s PR means next to nothing. It’s an almost verbatim copy of what DNDN said about Provenge in 2005.

The FDA cannot legally prevent a company from submitting an application even if the chances for approval on the first review cycle are de minimis.