News is definitely 'imminent' - ADVFN message NobbyGnome11 Jan 2021 13:41
A contributor on my Guild thread on ADVFN had a chat with RM today. He has regularly spoken to him in the last 6 months. His post is below.
Managed to get a quick chat with RM. Limited in what he could say without making me an insider, which I have been in the past, but didn't want to be currently. Please note this is my take on the conversation, so not words directly from RM.
All going 'to plan' and he's comfortable with where they are. Phase 3 will start 'imminently' (they will RNS 1st dose) and once started will roll out quickly. He's well aware of not 'missing' the 2nd wave of patients. There is ongoing global interest, with 20 countries lined up (they won't launch in all initially). Key is less starting the trial but in making sure it recruits quickly and completes.
The changes in the trial protocol (dropping the arm and reducing numbers) has delayed things by a few weeks. He said without this change the trial would have kicked off in December, but as above, means it will complete more quickly.
I asked about the early late debate and was reassured that patients who are already in the Cytokine storm are excluded from the trial (they are easy to spot apparently), and as the phase 2 results showed, even treatment 'late' (but pre storm and within 10 days of a positive test) responded well to SNG.
No issues with manufacture or supply of nebulisers, vials etc. Labelling is being done by hand given the numbers and the different languages, which is time consuming. They are currently scoping to be able to increase drug supply significantly from current plans, so they will be ready to upscale should it get approval, and also strengthens their hand in any future negotiations.
They have about 20+ staff and many more (another 20-30) working via 3rd parties on regulatory issues and other outsourcers. Relations with the CRO and NIHR are excellent.
He again reminded me that the phase 2 results are still probably the best results seen in any trial to date.
Home trial was mentioned and he said Dec and now Jan have been very busy and suspect it should be close to being fully recruited.
He's aware of shareholders interest and the guild and how frustrating it is when we have a treatment that should save lives, but they are moving as fast as they can to get it to patients.