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The Food and Drug Administration (FDA) was due to issue an approval decision regarding Biodelivery Science's (BDS) treatment for pain in cancer patients, Onsolis, by June 15th, but a Monday morning press release issued by the company stated that the FDA decision has been delayed. However, the time frame for the delay is expected to be short enough where the FDA did not feel the need to issue an extension letter.
Shares of BDSI soared to over eight dollars in early trading Monday only to resettle in the mid seven dollar range as investors await final word from the FDA.
The fact that the FDA informed Biodelivery that a decision is close and an extension letter would not be needed is a positive sign, in my opinion. A negative response would most likely have been accompanied by an extension letter so that the FDA could be perceived as acting 'by the book'. With the BDSI stock price slowly inching up over the past few months chances of an Onsolis approval are good.
In a Complete Response letter in August 2008 the FDA stated that the only deficiency in the New Drug Application (NDA) was the lack of a Risk Evaluation and Mitigation Strategy (REMS), a new requirement at the time. The REMS has since been submitted.
A final decision is imminent and I expect an approval for Onsolis bringing to the stock price to a range of between ten and twelve dollars.
Disclosure: VFC is long BDSI.
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