Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Lambourn
Well done
Can't make it myself as I am in the US.
Still holding 2.5m shares.
Appreciate it if you would post summary of meeting
Cheers
People will get confirmation today at the AGM whether the meeting has taken place or not, I don’t think it has taken place personally But will get confirmation today
From FDA guidance on type C meetings:
The official, finalized minutes will be issued to all FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days of the meeting.
So 30 days from when? I believe meeting was held several weeks ago and yesterday's rns was a contingency statement prior to AGM in lieu of the awaited FDA response. So response not September but mid July IMHO
Who is Art Deas
So it looks like we have 75 days for the FDA to respond to a Type C meeting, after doing some research on the FDA website that’s what it says for a Type C meeting so early September and we should have a decision
Art Deas comments really are key here, he sees Lupozor as the leading product in his entire portfolio… quite a statement!! Having met all the FDA's requirements, we are delighted to be seeking the FDA's final guidance on moving Lupuzor™ forward into the new international Phase 3 trial. We anticipate Lupuzor™ becoming the leading product in our portfolio and that it will be instrumental in bringing an innovative treatment to Lupus patients, which is not currently available on the market today."
CauldStream7
Agreed.
There seems to be a paucity of information on "what happens next".
I understand that the content of their meeting is minuted , with Avion subsequently being provided with a copy.
As regards timing, we could maybe take the Minerva response time of 35 days as part guidance:-
"WALTHAM, Mass., April 07, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company developing therapies to treat central nervous system (CNS) disorders, announced today that it has received the official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration (FDA) held on March 2, 2022."
Absolutely correct, type C meeting must have been held already.
Bought back in here today. Mcap of £18m for a much needed drug going into phase 3 trials? Crazy!
Lukehear: You state that the Type C meeting with the FDA has been requested by Avion.
But according to today's RNS, which states that " Avion has submitted, via a Type C Meeting, the positive results from the Lupuzor/P140 PK Study to the FDA".
Therefore, it seems that the Type C Meeting with the FDA has taken place and approval/guidance in now awaited from them as to whether the Avion design for the Phase 3 Lupuzor can go ahead with or without modifications.
Is there a time limit on when FDA must reply?
,
Agree we are now at the final hurdle and so close to this company waking up from its 4 year slumber… it will imo be an epic recovery once the phase 3 gets approved and gets underway, Art Deas is obviously very excited about it’s potential, Avion are clearly fully committed as they see Lupozor as been their future leading product, no wonder they paid £1.2m for IMM shares at 11p in the last placing, with Avions backing IMM could be a portfolio maker from this low levels there’s no doubt about that
IMM are edging closer to a defining moment.
The FDA are due to respond to the meeting request in 14 days.
"If a meeting request is denied, notification to the sponsor or applicant will include an explanation
of the reason for the denial. Denials will be based on a substantive reason, not merely on the
absence of a minor element of the meeting request or meeting package items."
Hopefully though the request will accepted, in which case "the Type C meeting should be scheduled to occur within 75 days of FDA receipt of the written meeting request " or Sept 9th 2022.
Fingers crossed !
Thanks Lambo. I missed the reference to a type C meeting with the FDA in today's RNS.
My thoughts exactly…
But Avion have put some coloring to the black and white :-)
On 4th May they were requesting final guidance from the FDA, now after receiving that guidance they hve submitted all the PK study data and requested a type C meeting which is excellent news as FDA now have a deadline by which to schedule a meeting and finally approve the phase 3 trial. We are now at the final hurdle and investors in at this level will be richly rewarded imo
Explanations are needed.
I have read the latest RNS with disappointment. It looks more or less the same as the wording of the RNS dated 4 May. It also announced "with delight" that Avion has was seeking final guidance from the FDA on the design of the Lupuzor P3 trial. In fact, the two RNS are so similar it could be a cut and paste job.
Can someone tell me if I have got this wrong?
I won't be investing here a single penny more, l just want my money back. At around 25p l will break even.
Ambiguous wording indeed Nolupus.
Market reaction a bit weird so far but then it is IMMU !
Dallo,
I think you should read the statement again
Meeting of the two companies = IMM + Avion, imo
MM totally agree, I am not adding here until a few questions are answered!
Trying to shake some out, try getting a quote to buy…. Impossible it’s NT, will be buying more once they get their book in order
See it as an opportunity to top up :)
Focus on the bigger picture.
….and the roller coaster is off again!!
The rabbit is out …
It is not tbh. The Bid will be dropped in order to catch out the last of the margin calls before any rise up.