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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.
I may have waited too long to begin experimenting with momentum outperforms, but seeing the approach backfire could be just as useful as seeing it succeed in CAPS. I've been a long-term skeptic of Gentium, given that all their late stage trials failed to achieve statistical significant results. Nevertheless, the company seems to have outmaneuvered CHMP by first gaining widespread acceptance through the named patient exemption and leveraging that acceptance into a rare reversal by CHMP on appeal. Quarterly defibrotide sales have been growing, although I am unsure how much EU approval will add given the widespread use of the drug in named patient programs. I am still dubious about the prospects for FDA approval but the PDUFA likely won't be until early 2015 and I expect the street to remain optimistic. Despite the impressive share price of 28 for a biopharma, the market capitalization is only 420M which is relatively inexpensive given the current permissive environment for small cap biopharma.
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