https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html This cancer organisation has an excellent breakdown of phases 1 to 4 as well as well as IND and NDA via FDA. Good clear language and well laid out. EG, "A group of 25 to 100 patients with the same type of cancer get the new treatment in a phase II study. They’re treated using the dose and method found to be the safest and most effective in phase I studies. Treatments that have been shown to work in phase II clinical trials must succeed in one more phase before they’re approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.
Most phase III clinical trials include a large number of patients, at least several hundred.
These studies are often done in many places across the country (or even around the world) at the same time."
What we have at the moment seems to be a phase 2-3 trial. Less humans, but ticks all the other boxes.
FDA has sent guidance to Biotron to enable a small trial for Covid infected humans. My take on this is that they need to check how humans dealing with Covid handle BIT225. We already have tonnes of data on HIV infected humans seeming to do very well. This looks like a quick way to dot the I's and cross the T's before the phase 3-4 and all that fast tracking business.
I am not an expert nor qualified. Please everyone, do you own research and due diligence. I have skin in the game.
BIT Price at posting:
7.6¢ Sentiment: Hold Disclosure: Held
