Open Label and WHO Solidarity Trials Trump Phase 3
What the market is missing on the latest announcement. The key is Open Label and the WHO Solidartiy Trials. Let me explain, because CATCO is in charge and is an advocate for LSALT for Lungs for Covid and is the Canadian contribution to the WHO Solidarity Trial, they will be able to most likely get all patients needed by sometime January 2022. But first let me explain Open Label, what this means is they will have 640 patients who are in the hospitals accross Canada all will get the standard of care for Covid at this time of Remdisiver however half 320 will also get LSALT treatment. I am told it takes around 2 weeks to see that LSALT is working for the lungs. Let's say they have gone thru 100 or so patients and all or say 90% are showing vast improvements. Then CATCO can ask Canada Health for EUA (emergency use authorization) that is how the Vaccines got thru so fast. Please see below that I got from Wikipedia on lthe adaptive design. I may be optimistic but being part of WHO Solidarity Trials is better than Phase 3, because of Covid and being Fast Tracked thru the normal 2 year process. Oh and let's not forget this is being funded by CIHR and Sunnybrook is overseeing it. I was shocked we are not higher so I bot more yesterday at $3.95 USD.
Adaptive design[edit]
The design of individual trials may be altered during a trial – usually during Phase II or III – to accommodate interim results for the benefit of the treatment, adjust statistical analysis, or to reach early termination of an unsuccessful design, a process called an "adaptive design".[19][20][21] Examples are the 2020 World Health Organization Solidarity Trial, European Discovery trial, and UK RECOVERY Trial of hospitalized people with severe COVID19 infection, each of which applies adaptive designs to rapidly alter trial parameters as results from the experimental therapeutic strategies emerge.[22][23][24]
Adaptive designs within ongoing Phase II–III clinical trials on candidate therapeutics may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, and coordinating design changes for a specific trial across its international locations.[21