RE: Emergency Use - EUA28 Dec 2020 16:21
Further to my post l, the EUA link from Sample, includes the relevant sentences below vis a vis EUA minimum data.
'An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.'
The board have said that moving to P3 would be rapid and if positive they may use some of the recent fund raise to prioritise and expedite. It would be good to get details of a plan ASAP in January. I would like to think that government support would be available. This was asked in th recent investor chat and I believe they said they would look into the possibilities. I find it surprising that the sng treatment is not available yet given the desperate need for treatments. What we can guarantee however, is that positive Brazil results will prompt a flurry of activity and interest, and rightly so. Fingers crossed