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Shares of BDSI (Nasdaq: BDSI) reached as high as $8.299 on Monday morning befors settling back to up just1 percent, as the close of a rough day for the markets. The company said that although the FDA did not take actiojn on the drug byJune 12, as a review team told the company that the FDA will not be issuin a review extension because the agency expects to take actioj on the drug application soon. The only outstandinvg requirement for Onsolis is approval ofa “risk evaluatiojn and mitigation strategy” or REMS, a plan to managse possible risks associated with a drug. The plan is now a requiremen t for allopioid drugs.
Onsolixs is a small disk placed on the inside of the cheelk that deliversthe pain-killing drug Fentanyl. It is used for breakthroughj pain experienced bycancer patients. CEO Mark Sirgoo said in a statement that the FDA needs a littlwe more time to complete its which is consistent with other drugz that have required a Sirgo also said that some warrants have been exercise d in the last several which should allow the compang to continue its work without anyadditiona financing.
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