PharmaCyte Biotech Inc (PMCB)

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A clinical hold occurs when the FDA contacts the sponsor-investigator and indicates that the study cannot start pending resolution of questions or concerns. The specific questions that the agency has are conveyed to the investigator, typically by telephone followed by a detailed letter. Upon receipt of the list of FDA concerns, the sponsor-investigator should respond to the issues cited in the letter in their entirety. The cover letter that accompanies the response should clearly indicate the response with a heading, “Clinical Hold Complete Response.” Likewise, the accompanying FDA Form 1571 should indicate by serial number and checkbox that it is a response to a clinical hold. The “clock” on the review process does not begin until all issues have been addressed and the responses have been received and acknowledged by the FDA.

The FDA should reply within 30 days of the receipt of the complete response from the sponsor-investigator. The agency will issue a letter that lifts the clinical hold (the study may proceed), places the study on partial hold (specific restrictions), or that the study continues to be on hold pending resolution of continuing questions. Until the FDA indicates that a hold has been removed, a study must not proceed.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435682/

So they want more information. I don’t see the problem with that.