I agree with you. There is a timeline of obligations whenever the decision is given to HEB management. The FDA will publish approvals shortly after notifying the company. Somewhere I read about a four day window for the company to announce approval news before it's on the FDA's website. On the other hand, I also read that denials are up to the company to position the timing. 30 days? Anyone know if there is a time constraint?
We do know that the FDA put a request in for animal toxic studies. From the 10-Q pg.22 signed Aug.7, 2009:
On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen® NDA. These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility. These studies have been substantially completed with summary reports expected to be issued to the FDA during the third quarter of 2009. Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010.
To the best of my knowledge the study has not been released or made public. If they wanted that last bit of information before decision time, then what Dr. Carter said about expecting news early this fall would make sense.
We only have a small bit of knowledge about what the FDA wants or needs to complete their decision.
IMO, we'll have their decision by October.
