Cel Sci Corporation (CVM)

[mikedel]

Cel-Sci should absolutely know the reason for the hold. They have elected, for some reason, not to disclose the reason.
I contact the company and they told me the request for expansion was submitted 30 days ago w/o an FDA response. Stating that they don’t know reason for the hold. I believe this to be a lie since the FDA attempts to resolve prior to a hold. See P&P below. The reason is well known. If due to the expansion, you would think that this could have been resolved without a hold.
It’s anyone guess what’s going on.

I. POLICIES AND PROCEDURES
The regulations in 21 CFR 312.42(c) require that when FDA concludes there may be grounds for imposing a clinical hold, FDA will "attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order." FDA experience is that most potential holds, particularly those based on inadequate patient monitoring, can be resolved through such discussion. However, if FDA determines that a study must be placed on clinical hold, it becomes subject to section 505(i)(3) of the Act.