>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.
“Its very rare that we see something that we actually go to the trouble of referring to SEC… it’s less rare that we see something that we would call the company up and say, ‘We noted your press release said no new studies were required for approval… maybe you didn’t read the letter to the end, but we asked you for a new study.’”
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