Cel Sci Corporation (CVM)

[Foxwoods Man]

Our Phase 3 Study has been placed on partial clinical hold by the FDA
We received a partial clinical hold letter from FDA stating that our Phase 3 study had been placed on clinical hold, precluding us from continuing the study except that patients enrolled prior to September 26, 2016 may continue to receive protocol-specified treatment at the discretion of the treating physician with written confirmation of their consent to remain on study after receiving an updated informed consent document. FDA’s partial clinical hold letter identified the following specific deficiencies: there is an unreasonable and significant risk of illness or injury to human subjects; the investigator brochure is misleading, erroneous, and materially incomplete; and that the plan or protocol is deficient in design to meet its stated objectives. In its partial clinical hold letter, FDA also identified the information needed to resolve these deficiencies. Although we believe we addressed each of the deficiencies identified by FDA in our response to FDA, we have also requested a face-to-face meeting with FDA. We will not be able to enroll any additional patients in the Phase 3 study unless FDA lifts the clinical hold. In addition, in the spring of 2016, the IDMC recommended to us that new patient enrollment should stop in the Phase 3 study, but patients already on study should continue to be treated and followed. We expect to work through the concerns raised by the IDMC while we work through the partial hold with FDA. However, if the clinical hold is not removed or if it is determined that the study has been compromised or if the IDMC does not allow enrollment to continue, the study may be terminated.

Does it just sound weird that the FDA would NOW say the underlined stuff when the study normally would have been finished?

What "significant harm" is there? TOTALLY surprised by that one....

..and in the spring they were told by the IDMC to freaking STOP the study?

This only gets better...