Biotech Values

[ilpapa]

Market can't seem to make its mind on this.

7:55AM Discovery Labs receives FDA recommendations and request for clarification regarding recently-submitted SURFAXIN (lucinactant) updated product specifications (DSCO) 2.39 : Co announced that the FDA has requested clarification and provided recommendations regarding the recently-updated product specifications for SURFAXIN. Discovery Labs plans to provide a response to the FDA within two months. FDA procedure provides up to four months for FDA review of the information provided. If its plan is successful and the FDA agrees with the response, Discovery Labs expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013. The recently-received FDA correspondence includes a request for specific information intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method, including:

Recommendations regarding how the product specifications should be documented and notated
A specific recommendation for the upper limit of a single product specification that Discovery Labs can readily accept
A request for two existing and readily available documents related to the improved analytical chemistry method
Request for supporting data using the recently improved and revalidated analytical chemistry method that is being generated from recent SURFAXIN batches.