Troy. feel your pain, but there is an end game and it's submission of MAA and then the real clock begins with that PR release. I personally cannot see having another ASM with no MAA submission, we are already 5 months into 2023. Upon submission and acceptance I expect an approval decision within 4 months, then FDA approval within another 120 days, at least that is my timeline thoughts. So for UK approval in 2023 I think we need have submission by end of August at the very latest. I expect NICE (government subsidy approval) to happen in short order upon MAA submission since MIA is now approved.
My timelines after MAA Submission (give it 4 months / 120 Days at latest)
End of May - Approval in Sept 2023
End of June - Approval in Oct 2023
End of July - Approval in Nov 2023
End of Aug - Approval in Dec 2023
I cannot make judgement on the insanity of the SP until submission and approval in the UK, at that point I will re-access how the SP moves and see if along the way any partnerships talk heat up.
Plans for 2023 Per ASM
Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year. The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license,(completed) which is one of the pre-requisites for submission of an application for product approval. In parallel, the top priority and intensive focus will be continued preparation of an application package for product approval, as well as the supporting documentation. The Company already made substantial progress on the application package during 2022, and the Company plans to submit an application as soon as possible after the pre-requisites and preparations are completed.
During 2023, the Company anticipates that additional key areas of focus will include:
Continued preparations for scale-up capability, with further implementation of streamlining product “release” processes;
Expansion of the operation in Sawston following completion of the Phase 1B buildout;
Continued development of the Flaskworks system, including choice of the system version to take forward;
Commencing the pediatric clinical program required under the PIP;
As resources permit, pursuing clinical trials with combination treatment regimens.
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