Weeks of delay ended Thursday when John McMichael got the nod to test his COVID cure.
The federal Food and Drug Administration gave its approval for the pilot trial, which Mr. McMichael said will start next week at the latest.
The Wright scientist spent more than a month completing paperwork and then waiting on the FDA for the okay to test his product, TML, which has already been shown to cure coronavirus.
“For us, it’s a very big step,” Mr. McMichael said. “It’s the traditional way to get a new drug on the market.”
Doctors in his nationwide Beech Tree Labs have found TML to be successful with COVID patients, but the drug needs FDA approval to be sold publicly.
Frustrated with the long delay, Mr. McMichael nonetheless praised the FDA’s diligence.
“In their defense, they really made a thorough investigation,” he said, “and they gave us information that will help with the study.
“The FDA gave us the permission to proceed. In effect, they said it’s worth the risk. It gives us a sense of legitimacy.”
So far, there has been little or no risk shown with the Beech Tree Labs doctors’ work. They’ve demonstrated TML cures COVID within four to 48 hours.
“The results have been consistently positive with no adverse effects,” Mr. McMichael said.
The pilot trial will be in Salt Lake City. Twenty COVID patients will receive TML, and 20 will get a placebo.
The trial will be virtual, and nurses will monitor patients remotely.
The trial will take two weeks for each patient, and Mr. McMichael hopes “everything is wrapped up by the end of summer.”
Optimistic about the trial, Mr. McMichael said that “we put all our resources into this, and that shows our confidence in it.”
The pilot trial isn’t the final step. Assuming TML clears that hurdle, there will be a pivotal trial, involving 200 to 250 patients, afterwards.
If TML passes both trials, Mr. McMichael will likely work with a large pharmaceutical company to produce the drug.
“We’ll talk to the bigger guys,” he said. “The volume would be way beyond what we could do.”
Pharmaceutical companies have already shown interest, he said, and so have other countries.
“We’ve been contacted by several countries that heard what we’re doing,” Mr. McMichael said.
“They offered to do the trials or buy the drug. They’ve been devastated by the virus.”
Still, he’s going ahead with the Salt Lake City trial.
Mr. McMichael developed TML about 20 years ago as a successful treatment for herpes and influenza viruses.
Doctors who have relationships with COVID patients could use TML, and those with Beech Tree Labs––and some locally–-did so with success.
Now Mr. McMichael is seeking FDA approval and then, a wider patient audience.
“All we want to do is help a few people,” he said.