John McMichael is still waiting for the go-ahead to have his COVID cure tested in hopes that it can be released to the public.
“This is the worst week ever,” the Wright scientist said Friday. “There’s been one delay after another.”
Although doctors in Mr. McMichael’s nationwide Beech Tree Labs have found the product, TML, is successful with COVID patients, TML needs Food and Drug Administration approval to be available to the public.
For two months, Mr. McMichael has been processing FDA paperwork and setting up the first trial test, based in Salt Lake City.
He sent all the paperwork to the FDA, and “now we find out things we should have been told about before,” Mr. McMichael said.
“It irks my soul.”
One delay is three days for the FDA to format the paperwork. . .in India. It’s all done electronically, however, so the fact that it’s done in India isn’t an issue, Mr. McMichael said.
Another three days is for an Institutional Review Board––citizens from around the country––to also review the paperwork.
“These two or three days add up,” Mr. McMichael said. “This is the week I hoped the trial would be finished. Now I hope that next week it will start.”
FDA review may be another delay. Mr. McMichael was told the FDA has 2,200 COVID cures to review, “and that’s an awful lot to move along with.”
But he has help. Mr. McMichael enlisted Assemblyman Chris Tague and former Assemblyman Pete Lopez to urge the FDA to move TML up the line.
The Salt Lake City trial will include 40 COVID patients. Half will take a placebo, and half will take TML.
Patients will keep diaries and record body temperature, respiration rate, oxygen saturation of blood, symptoms and physical and mental well-being. Patients will be phoned to report the data.
If the Salt Lake City trial is successful––and Mr. McMichael believes it will be––there will be a larger Pivotal Phase 3 Trial, along with two options.
One is that Mr. McMichael’s team will have a multi-site trial with 200 to 250 patients.
Another is to partner with a large drug company for the trial.
“It appears they’re interested,” Mr. McMichael said of the drug company. “And they have more resources than we do.”
Despite the numerous delays over two months, he remains optimistic.
“We expect it to go very quickly once the IRB and FDA approve,” Mr. McMichael said.
He developed TML about 20 years ago as a successful treatment for herpes and influenza viruses.
Mr. Michael’s physicians tried TML on COVID patients, and it worked; recovery is within four to 48 hours.
Doctors can use TML without FDA approval if they already have a relationship with a patient, and dozens have done so successfully.