ulyanaimiiurebor.blogspot.com
Shares of BDSI (Nasdaq: reached as high as $8.29 on Monday morning before settling backto $6.83, up just 1 as the close of a rough day for the The company said that although the FDA did not take action on the drug by June 12, as expected, a review team told the company that the FDA will not be issuing a reviews extension because the agency expects to take actioj on the drug application soon. The only outstandingb requirement for Onsolis is approval ofa “risk evaluation and mitigation strategy” or REMS, a plan to manag e possible risks associated with a drug. The plan is now a requiremen for allopioid drugs.
Onsolie is a small disk placed on the insids of the cheek that deliversthe pain-killintg drug Fentanyl. It is used for breakthrough pain experienced bycancerd patients. CEO Mark Sirgo said in a statement that the FDA needxs a little more time to completeits review, which is consistent with other drugs that have require a REMS. Sirgo also said that some warrantsx have been exercised in the last several which should allow the company to continue its work without anyadditional financing.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment