Town of Wright scientist John McMichael expects to have his cure for COVID-19 undergo clinical trials this week.
That’s the next step to get his product, TML, to an ailing public, though there are more steps ahead.
Physicians in Mr. McMichael’s Beech Tree Labs have been successfully treating COVID-19 patients with TML nationwide, but the product needs approval from the federal Food and Drug Administration before it’s released to the full public.
The FDA must also give the go-ahead for the clinical trials this week, and Mr. McMichael believes that will happen.
“All our paperwork was submitted,” he said Monday. “It’s just up to our buddies at the FDA.”
A lab in Salt Lake City will do the trials remotely or virtually with 40 COVID patients. Some will be given a placebo; others will get TML. The trial lasts 14 days.
Because TML has had success with COVID patients already, Mr. McMichael believes the clinical trials will prove his case.
“We have every reason to believe it will,” he said. “I’d be very surprised and horribly disappointed if it didn’t.”
Assuming TML passes the trials, it will go to what Mr. McMichael called the Pivotal Phase 3 Trial with 250 patients.
“That will be at multiple sites, and it’s still virtual,” Mr. McMichael said. “That’s the prelude to okay it for marketing.”
Doctors can use TML without FDA approval as long as they have a relationship with a patient. That’s a relatively small number, however, with the steady increase in positive COVID cases across the country.
“We’ll see if we can help a little,” Mr. McMichael said. “We’ll keep our fingers crossed, and our eyes and our toes, too.”
He developed TML about 20 years ago, and it’s been successful treating herpes and influenza viruses. In what he described as trial and error, Mr. McMichael tried TML on COMID patients, and it worked; recovery is within four to 48 hours.