RE: operational update6 Mar 2023 21:32
evening bignose.pleased to see a fairly comprehensive update at last (why now?).china seems to be progressing well and if it continues in this vein will clearly beat FDA to the finishing line.it is going to be a bit later than i might have hoped (i was going for H1 2024) but that's just the way it is.
no mention of singapore,but as we've previously commented ,it is perhaps simply of no great significance in view of the population size.agree it could have been easily incorporated though.
as to FdA, clearly there are some issues, but at this stage im happy to accept ERP's comments that the agreed pathway is a major positive in proceeding with the us NDA. of course it may just be the usual overly optimistic spin, but time will tell. one specific point.is the wording that signing the SPA should allow the company to advance negotitions to a final conclusion in respect of out licensing, a slightly more positive statement in tone and phraseology than the previous references to this outcome? i haven't checked the previous wording on this point but it just felt a little moe definite than my previous impression.probably wrong and as you know i have been and remain highly sceptical of them getting a deal before approval,but would be happy to be proved wrong.
final point re DLI, they do refer to "first customers" for senoclock. is this new? again haven't checked back,but if they are new (and are genuine paying customers as opposed to the sometimes rather loose concept of "customer" sometimes put forward by Aim and Aim type companies for promotional purposes) then it would very slightly encouraging if some sort of traction is actually being gained. not getting my hopes up,but just pointing it out.
i do have a number of other thoughts,but a bit amorphous atm.