RE: Long Covid Analysis still ongoing...25 Oct 2022 22:00
Mani, I don't think an EUA is viable unless something dramatic happens with hospitalisations and deaths this winter (i.e. a new more dangerous, vaxine evasive, anti body resistant strain emerges). Any new LC data isn't going to change that.
The ONLY data from Sprinter which really matters is the deepdive analysis showing 70% efficacy in reducing progression to serious illness / death for those most in need (i.e. respiratory issues with oxygen level <92% and breaths per min 21>). This pretty much replicates the benefit shown from phase 2 and on top of a much improved SoC.
While a third of the patients in the Sprinter trial broadly fell into this category, it is an unfortunate fact that the sample size is still considered too small for an EUA. It might be different if Sprinter had been 2,000 to 3,000 patients but it wasn't. That is why RM stated he didn't envisage commercialisation within 12 months.
Confirming this data, presented at the ATS, is the most important / pressing issue for Synairgen as it is pretty obviously the fastest route to market. It might even mean the ifference of the company surviving or not let alone making or being worth alot of money. I find it highly unlikely that this result isn't on the radar of BP, but RM has to exhaust a PT first. Let's hope he has been proactive on this front.
If you really believe the LC data can outweigh what is already know and lead to a EUA then good for you, but I really do think it is a pipe dream if I'm honest.
GLA