I'd be very careful with DNDN, personally I'm not invested in it but I believe that it will gradually drift lower until it's closer to an approval decision. It is of course this decision that will make, or break the stock price.
While I believe TNFerade is a slam dunk once the company has sufficient data to approach the FDA, provided the future data equals that of the past. I cannot say the same of Provenge, don't get me wrong, I believe it's good, but I don't know that it's so good that the FDA won't ask further questions, or ask for more. I've seen the FDA turn down drugs that were thought to be worthy of approval by all who had an opinion, including several Analysts who uncharacteristically stuck out their neck, the drug was always later approved, but the company tanked on the news.
Of course this could be true of TNFerade, in spite of my feeling it's a slam dunk, but when you're dealing with the FDA, delays are practically a part of the game they play.
I believe that well before we're seeking FDA Approval we'll have had two partnerships and an order for FMD Vaccine, this will put the stock at levels that haven't been seen in years, and perhaps that have never been seen. At that point, an FDA delay could bring the stock down 30 to 50%, on the other hand, an approval just might double the price or more. Much of this will be determined by the terms of the partnerships that are revealed. It's also very possible that a partner taking over the TNFerade trial funding may choose to fund additional trials even before approval has been obtained. This to could spur the stock to far higher prices as suddenly we'd be looking at markets far bigger than Pancreatic Cancer, even if they're a few years downstream. What's important is, does the early data reveal efficacy, if it does, the drug will be used off label until the approval is finally obtained.
Gary
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