John McMichael is hoping to have his COVID-19 cure tested next week with an eye towards eventual approval by the Food and Drug Administration.
The Town of Wright scientist’s product, TML, has been successful treating dozens of COVID-19 patients, but it needs FDA approval for a wider public audience.
Getting TML into clinical tests has already taken a couple of weeks, however.
“We’ve been pushing, pushing, pushing and jumping through FDA hoops,” Mr. McMichael said Monday. “There’s a lot of paperwork.”
The group making TML must use good manufacturing practice, which is time-consuming, though “the group got a break,” Mr. McMichael said.
“There was a change in their scheduling and we moved up the queue.”
Mr. McMichael planned to have a Memphis lab do the clinical testing, but he’s also talking with one in Salt Lake City that would do the tests remotely.
Patients would receive their medicine––TML for one group and a placebo for a control group––and instructions.
“It’s pretty amazing,” Mr. McMichael said. “They can take your temperature from 1,000 miles away and monitor how many times you cough.
“And it’s nice because patients don’t have to go to the clinic, and the clinic doesn’t want them there.”
He expected to hear by Tuesday, yesterday, whether the Salt Lake City lab would take on the testing.
Cost is a factor as well, Mr. McMichael said.
If the tests happen next week, he hopes to be finished by the end of May.
“It seems like a long time, but it isn’t,” Mr. McMichael said.
Meanwhile, he’s still supplying TML to doctors in his Beech Tree Labs, a nationwide network of physicians, veterinarians and scientists.
Doctors can use TML without FDA approval as long as they have a relationship with a client.
One physician was to meet with the governor of South Carolina with plans to have TML tested in a medical school there, Mr. McMichael said.
“The avenues are opening up a little,” he added.
Mr. McMichael developed TML about 20 years ago, and it’s been successful treating herpes and influenza viruses. In a trial-and-error scenario, he decided to try TML on COVID-19 patients, and it worked; recovery is within four to 48 hours.
“We’re confident it’s safe and it works,” he said earlier, but TML still needs FDA approval to be released publicly.