outlook10 Dec 2022 19:32
Following is the relevant part of the November RNS:
‘.. the MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority, or further support, of the non-clinical data submitted as part of the application to approve the clinical study. Sareum and its advisors are seeking additional clarification from the MHRA’.
So,
1. We are currently seeking clarification from the MHRA.
2. Presumably this is in relation to the ‘further support’ required.
3. The alternative, a review by the good practice body, is presumably one SAR would prefer to avoid, since a review by a third party would certainly lead to delay and the outcome may be unpredictable.
4. When we are told what ‘further support’ is needed, presumably we will request same from our contract partners. One can see this may take some time.
5. Too many ‘presumably’s. It would be helpful to receive some clarification.
6. Will we be informed when we reach stage 4? Wait and see.
7. It seems unlikely this can all be sorted before 2023 Q2. Maybe Q3. At that stage the best outcome is that we can resubmit our application.
8. Meanwhile the share price will have to sink or swim on its merits.