Pharma, R&D

The FDA refuses to lift a clinical hold on Cel-Sci’s PhIII drug

Penny stock biotech, Cel-Sci, remains in the FDA’s dog house.

Last fall, the biotech reported that the FDA had put their Phase III study for Multikine on partial hold. This morning, the company reported that the FDA had upgraded that to a full hold, and the biotech outlined some of the remaining issues that continued to keep the clamp on.

That shift from partial to full hold, the company notes, won’t make much difference because dosing has ended.

Investors, though, haven’t stopped beating the stock up. Its badly battered shares dropped 33% in pre-market trading this morning, down to a mere seven cents at latest glance.

The key remaining problem, according to Cel-Sci $CVM, is an investigator’s brochure and letter, which still don’t resolve regulators’ problems with the 938-patient study. Notes Cel-Sci:

“We have completed the review of your April 19, 2017, submission and have concluded that removal of the clinical hold is not warranted since item 3 of the October 15, 2016 letter has not been resolved. In addition, we have identified new deficiencies in your April 19, 2017, submission.” The FDA directed that: 1) The IB and the “Dear investigator” letter should contain specific statements and data which were not included in the proposed texts we had submitted in April 2017 and 2) Some of the statements that were included in the proposed texts accompanying our April 2017 response should be removed.

Cel-Sci has sued its CRO inVentiv Health over the late-stage program. InVentiv, though, has said that the suit was only filed so Cel-Sci could avoid paying its bills.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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