As I suggested In my recent timeline of forthcoming news events, I believe the speed at what is going to occur will take many by surprise.
The first cab off the rank should be the trial outside of the US, hopefully in Australia. Not only will this be set up quickly, I suspect this is well and truly underway, but the results will come quickly too, and I’f I’m not wrong, will add to the overall FDA appraisal.
The trial afterwards, being CTAP, will stand alone, but it’s speedy acceptance will be based on the already established high safety profile from HIV, and if the interim analysis of C19 data returns successful - like imitating our recent mice trials - and any data from the forthcoming ‘Aussie’ trial is likewise successful, then CTAP will come to a speedy resolution, and an EUA will become a mere formality.
Plenty of syzygy to occur though for this optimistic outcome, but there is nothing yet indicating otherwise, apart from the possibility to BIT225’s safety profile being diminished in the FDA’s eyes for a CTAP due to any evolution in the compound since previous HIV trials occurred. But this possible damper will be based on information that we are not privy too, and for good reason.
An upside though from this possible downside, is that any new data from the ‘Aussie’ trial should add enormous bearing on an FDA decision. This is possibly why such a trial will occur very soon. For those not following the story too closely, this new trial will be a phase2/3 human COVID trial outside of the USA.
My guesstimate of its commencement is immediate, say, prior to Jesus’ birthday.
Plenty of very worthwhile other news in development. No, the second coming unlikely, in case the detractors require a new angle. The old ones are worn out.
Expand
