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Re: AlpineBV_Miller post# 90087

Wednesday, 02/03/2010 6:34:15 PM

Wednesday, February 03, 2010 6:34:15 PM

Post# of 252299

Provenge was designed with manufacturing in mind. It was designed by people who watched a company they loved be swiped for a song because of an inability to solve manufacturing issues. They have spent the entire 10+ years we have covered the company creating a system to make sure that doesn't happen again. That's worth knowing, I think.



Didn't the CRL issued 3 years ago address CMC deficiencies? Sure 3 years is a lot of time to get things under control but given that its a novel manufacturing process and has to handle thousands of batches (not hundreds for the clinical trials) there is bound to be a lot of scrutiny. Therefore looking at DNDN as an investment at this stage where its at a MC of 4B thats just too much risk IMO. Not tying to be a drama queen bear but just trying to point out potential risks in investing in DNDN at this stage.It will eventually get approved but when is the question.

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