Cyclo Therapeutics Inc (CYTH)

[JellyDonut]

The 483 issued to the NIH brings up several questions – some of which may not be able to be answered due to NIH’s lack of an effective monitoring process.
Who’s in charge of clinical trial manufacturing? How long has NIH been in noncompliance with the basic principles of cGMPs and aseptic processing? How many clinical trial subjects are at risk? What would have happened if this letter was received by a for-profit pharma company?

Fungal and bacterial contamination went unaddressed for months at a now-shuttered National Institute of Health pharmacy, inspection reports show. Drugs untested for safety were released to patients receiving experimental treatments at a highly regarded clinical center.

The Washington Post reported that the contaminated vials contained two fungi that are the “most common cause of fatal fungal infections” – aspergillus (4).

“It’s troubling that an institution of NIH’s calibre had such serious deficiencies,” says Michael Carome, director of health research at Public Citizen, a non-profit watchdog organization in Washington DC. “These clearly could have put patients at risk of harm.”

The National Institutes of Health suspended production of clinical-study drugs for 46 different clinical trials, after two vials of drugs were found to have fungal contamination and federal inspectors found deficiencies in the way drugs are managed.

But I'm just making stuff up.