Gentium S.p.A. (ADR) (NASDAQ:GENT)
A biopharmaceutical company engaged in the research, development and manufacture of drugs to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments.
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Zoicks! How did I miss that late rush on Genta on Wednesday? Really, I can't take my eyes off some of these stocks for a minute before they're reaching into the cookie jar.
I'm pretty confident that there's no new reason to be optimistic about Genta. Defibrotide sales under the named patient programs seem to have topped out around 5M Euros quarterly. As noted previously, the company withdrew the defibrotide NDA in August after getting a heads up that the FDA would refuse to file. The only significant new development is that the company received the CHMP day 120 list of questions. In October they issued a press release stating they would respond to the questions by the end of 2011. At the end of 2011, they issued a new press release that they would respond to the questions in Q1 2012. Why didn't I ever use that tactic with my chemistry teacher?
I don't think defibrotide will ever be approved in the US or Europe. The data simply doesn't support it, although after three years many people seem to have forgotten the results of the trials. Meanwhile, the company's end run around the regulatory bodies through named patient programs is likely unsustainable.
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GENT solves serious medical problems, for which there is no cure. Other clinical trials on horrible diseases keep evolving. Long Gent
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Tailored single-strand DNA and RNA aptamers!
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I used to read their magazines when I was a teenager. Good stiff. I mean stuff.
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THey are not on solid ground yet.
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