Now, here is the response Dan submitted when I asked what the grounds for the hold were:
"When the FDA's response is received, we'll be able to answer your question. Until then, we will await the FDA letter.
Thats what Dan told me when I asked why there wa a hold. Supposedly, ACT does not know if there even is a hold yet for all they know the letter can be acceptance. All they know is a draft is in process. Hope that helped.
"(d) Imposition of clinical hold. The clinical hold order may be made by telephone or other means of rapid communication or in writing. The clinical hold order will identify the studies under the IND to which the hold applies, and will briefly explain the basis for the action. The clinical hold order will be made by or on behalf of the Division Director with responsibility for review of the IND. As soon as possible, and no more than 30 days after imposition of the clinical hold, the Division Director will provide the sponsor a written explanation of the basis for the hold."
If ACT would not proceed by their own decision, they would know why they are not proceeding. Everything indicates that the FDA issued a hold and the company will get the reason in a few weeks. Most likely in the next 30 days.