Replies to post #886 on Heron Therapeutics Inc. (HRTX)

[crammerfool]

wallstarb, I have not seen you reference this from the news report found after the Clinical section.

Some of the FDA’s points were addressed in recent NDA amendments by A.P. Pharma that the Agency did not review prior to issuing the Complete Response Letter. The Company believes that these amendments may address some of the issues raised in the Complete Response Letter. The FDA has indicated that A.P. Pharma may incorporate applicable sections of these amendments by specific reference in its resubmission. The Company will be contacting the FDA to request an End-of-Review meeting to discuss the Complete Response Letter. A.P. Pharma is committed to expeditiously resolving the remaining issues required for FDA approval; however, based on the anticipated time needed to prepare a resubmission, the Company does not anticipate the commercial launch of APF530 in 2010.

I think we will find out more in the news conference and anything before then is purely speculative to what has all transpired and what was discussed with the FDA and AP Pharma.