InvestorsHub Logo
icon url

Smitty5150

07/09/23 6:29 AM

#607966 RE: Lykiri #607963

Doesn't make sense to have a pre-submission meeting with the MHRA before you can provide certificates for all manufacturing functions IMO



They already had the manufacturing license's needed (via Advent- Sawston)in the UK by 6/1.
icon url

hoffmann6383

07/10/23 10:13 AM

#608192 RE: Lykiri #607963

This is great info Lykiri. I agree with this timeline. I believe we have the hedge fund social media army creating a fake expectation the MAA has already been submitted and we should expect approval at the next PR. That way when we do see a MAA submission PR it can be spun as a disappointment by the hedge fund social media army.

I'll be very happy once the MAA submission is PR'ed because that is a near certain countdown to approval.

Thanks again for the insight into the timeline.
Bullish
Bullish
icon url

flipper44

07/10/23 10:16 AM

#608193 RE: Lykiri #607963

Not necessarily. Others have already contacted MHRA on this subject, which was already discussed, and rolling applications can be structured more fluidly and adapt to the circumstances.