RE: Today's runs28 Mar 2024 15:20
Had a couple of re-reads and i have to say my principal reaction is one of relief. i had been seriously concerned that the months of radio silence were indicative of not just delay,but rather of the occurrence of some fundamental and insurmountable problems,which would put an end to both china and us objectives. so, at least so far as china is concerned, i was relieved to see that things are still on track, albeit with an unwelcome delay on the manufacturer and supply front. if they do indeed complete the agreement in that respect and the submission by the end of this quarter (not a lot of time there) then it will be a positive and very welcome step forward.
the fda position is still very unclear, but at least they are not saying that the process has run its course and is now dead in the water, so some relief there also.
as to the suggestion that a manufacturing and supply agreement is unlikely ever to be completed for china, the words "as the agreement has now been finalised" do appear, even to someone of my limited intellect, to be fairly unambiguous. i accept that regent's history does lead one to be cynical, or at least cautious,as to the accuracy of formal statements,but for the time being i am prepared to go on its face value until proven otherwise.
i note the reference to SPA request in november. whilst not absolutely clear, i take this to mean that a request was made in november and that the resulting questions are now being addressed. the outcome, i accept,remains uncertain, but still a slight hope there. tbc