I did not cover this part of the May 27, 2009 "Investor FAQ" document, in my original post -- but here it is:
. . . .Q: Can you provide an update on the PEGINTRON melanoma regulatory application in the U.S.?
A: Schering-Plough has amended its application with the Food and Drug Administration (FDA) for the use of PEGINTRON (peginterferon alfa-2b) in the adjuvant setting in node positive melanoma. The company anticipates a six-month review by FDA.
The submission of this amendment was in response to a Complete Response Letter received in March 2008 from the FDA regarding its supplemental biologics license application for melanoma. In the letter, the agency requested additional information and clarification of submitted data.
Outside the U.S., the application is currently under review in selected countries. . . .
It is interesting that it took Schering-Plough over a year to collect and finalize the response to FDA, on melanoma. Is this [yet another] "please read between the lines" version of disclosing potentially-disappointing future news? I dunno. In any event, here is an image from an archived piece of mine on the main market for Schering-Plough's Pegintron: