The days, weeks and even months drag by, and John McMichael is still waiting for the trials to test his cure for COVID.
His product, TML, has been found to treat COVID successfully, but the federal Food and Drug Administration must approve it before TML is released to the public.
The trial is the first step for approval, and Mr. McMichael, whose lab is in the Town of Wright, expected the trial would be finished months ago.
“I thought this would be wrapped up by the end of June,” he said Monday. “It’s beyond frustrating.”
The trial is to be done with 40 COVID patients; 20 will receive TML, and 20 get a placebo. It’s also to be done remotely, and the first site is Salt Lake City, Utah.
“But there aren’t nearly enough patients,” Mr. McMichael said.
He’s planning to open another site in New Orleans by the end of this week or beginning of next. Mr. McMichael hopes that trial takes three to eight weeks.
“That seems slow,” he said, “but compare that to Salt Lake City. . .”
Mr. McMichael may also go internationally. Via a contact in New York, there may be a trial in Turkey.
A successful trial in Turkey may not be acceptable to the FDA, “but they may use it for their citizens there,” Mr. McMichael said.
Doctors in Mr. Michael’s Beech Tree Labs, a national network of scientists and physicians, have been successfully treating COVID patients since early spring. Recovery comes in four to 48 hours, Mr. McMichael said.
If a doctor has a relationship with a patient, he or she can provide TML. FDA approval is essential for a wider market.
If the early TML trials are successful, there will be a larger pivotal trial with 200 to 250 patients. If that’s successful, Mr. McMichael will work with a larger pharmaceutical company to produce TML for the public.
“I never would have guessed it would take this long,” Mr. McMichael said. “It works. We’re not quite ready to give up.”
Mr. McMichael developed TML about 20 years ago as a successful treatment for herpes and influenza viruses. In a trial-and-error process, doctors found it was also successful in treating COVID.