Cel Sci Corporation (CVM)

[mikedel]

The reason is probably (ii) since safty is not an issue.

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(2) Clinical hold of a Phase 2 or 3 study under an IND. FDA may place a proposed or ongoing Phase 2 or 3 investigation on clinical hold if it finds that:

(i) Any of the conditions in paragraphs (b)(1)(i) through (b)(1)(v) of this section apply; or

(ii) The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.
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(b)(1)(i) through (b)(1)(v)
(i) Human subjects are or would be exposed to an unreasonable and significant risk of illness or injury;

(ii) The clinical investigators named in the IND are not qualified by reason of their scientific training and experience to conduct the investigation described in the IND;

(iii) The investigator brochure is misleading, erroneous, or materially incomplete; or

(iv) The IND does not contain sufficient information required under 312.23 to assess the risks to subjects of the proposed studies.

(v) The IND is for the study of an investigational drug intended to treat a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of a risk or potential risk from use of the investigational drug of reproductive toxicity (i.e. , affecting reproductive organs) or developmental toxicity (i.e. , affecting potential offspring).