Cellegy Pharmaceuticals (CLGY) Message Board

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Biotech / Medical : Cellegy Pharmaceuticals (CLGY)

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To: Sergio H who wrote (244)	4/24/2002 8:09:51 PM
From: Arthur Radley	Read Replies (1) of 322

I would like to think this news out tonight will be a positive for CLGY, as this is a competitor's product that they are withdrawing the NDA... Novavax, Inc. Receives Comments From The FDA To Hold Conference Call Thursday, April 25 At 9:00 AM ET COLUMBIA, Md., April 24 /PRNewswire-FirstCall/ - Novavax, Inc. (Nasdaq: NVAX - news) today announced that the Food and Drug Administration (FDA) has completed its review of the Estrasorb(TM) New Drug Application (NDA). During the review process, no issues regarding the efficacy or safety of Estrasorb(TM) have been communicated by the review division. The agency has requested additional information with respect to the Chemistry Manufacturing and Controls (CMC) section of the filing. Based upon ongoing discussions with the FDA, Novavax believes the most advantageous approach to resolving the outstanding CMC questions is to voluntarily withdraw the NDA and resubmit once all the responses to the CMC questions have been prepared. Novavax continues to work together with the FDA in order to submit the additional information in a timely fashion.

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