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Shares of BDSI (Nasdaq: BDSI) reached as high as $8.29 on Monday morning before settling backto $6.83, up just 1 as the close of a rougjh day for the The company said that although the FDA did not take actiom on the drug by June 12, as expected, a revieaw team told the company that the FDA will not be issuiny a review extension because the agencyh expects to take action on the drug applicationh soon. The only outstanding requirement for Onsoliz is approval ofa “risk evaluatiom and mitigation strategy” or REMS, a plan to managr possible risks associated with a drug. The plan is now a requiremenr for allopioid drugs.
Onsolis is a smalkl disk placed on the insidw of the cheek that deliversthe pain-killing drug Fentanyl. It is used for breakthroughh pain experienced bycancer patients. CEO Mark Sirgio said in a statement that the FDA neede a little more time to complete its which is consistent with other drugs that have require da REMS. Sirgo also said that some warrantx have been exercised in the last several which should allow the company to continue its work withouf anyadditional financing.
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