Hemispherx BioPharma (HEB)

[NickPar]

Diane Will and I had a conversation late Wednesday afternoon. She called after I emailed her requesting clarification of Dr. Carter's statement about the FDA decision.

From our discussion I felt that this was important:

The FDA had two days of Advisory Committee meetings that ended Wednesday.
Preparation leading into those seldom held meetings were paramount.
The PDUFA date from those meetings is in October.
Our NDA is in a rather small department of the FDA.
Manpower issues are a factor.

We surmised that with the meetings over our rather small world should be right up front and addressed. Should be...

You be the judge from these 2 additional factors:
1) A vacation in May caused a delay since no one else addressed HEB's PDUFA.
2) The FDA's performance continues to suffer under the reins of the newly appointed Dr. Hamburg.
Should we have our decision before October?

What Dr. Carter said about our decision is just a good conjecture, IMO.

GLTA