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Shares of BDSI (Nasdaq: BDSI) reached as high as $8.2i9 on Monday morning before settling backto $6.83, up just 1 as the close of a roughy day for the markets. The company said that although the FDA did not take actionh on the drug byJune 12, as a review team told the company that the FDA will not be issuing a review extension because the agencty expects to take action on the drug applicationh soon. The only outstandiny requirement for Onsolis is approval ofa “risk evaluatiojn and mitigation strategy” or REMS, a plan to manag possible risks associated with a drug. The plan is now a requiremenft for allopioid drugs.
Onsolis is a smalkl disk placed on the insidee of the cheek that deliversthe pain-killinb drug Fentanyl. It is used for breakthrough pain experienced bycancee patients. CEO Mark Sirgo said in a statemeny that the FDA needs a littlde more time to complete its which is consistent with other drug that have requireda REMS. Sirgo also said that some warrantas have been exercised in the lastseveralk weeks, which should allow the companhy to continue its work without any additional financing.
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