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lambo - the RNS states "Further to our last update on 4th May 2022, Avion has submitted, via a Type C Meeting, the positive results from the Lupuzor™/P140 Pharmacokinetic ("PK") study to the FDA". To me, that suggests the Type C meeting has already taken place. What makes you think different?
Lambo not Lambourn..sorry
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."
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
When the US opens this should go mental, Art Deas is incredibly successful and a billionaire, for him to say they want Lupozor to be their lead product is absolutely huge and shows the ridiculous potential Lupozor has to be one of the leading products in a $10 billion market
If the SP rises like it did in 2018 on the last P3 then we should >15p by close today and another jump tomorrow to >20p
Fingers crossed there are larger buyers who listen to Avion and take the plunge.
I agree, and also by having a US partner on our side will certainly help the FDA process. I think after these waiting investors will be rewarded finally.
Any drop would be a buying opportunity now
The comments of the top man in the Alora Pharma Group Art Deas are the most salient and interesting
saying Lupuzor will be the biggest product in company ...very affirmative statement after meeting the FDA in Alora's HQ in Georgia .
Quite a statement by a multi Billionaire owner of Avion Art Deas, Chief Executive Officer of Avion further commented: "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."
Fantastic news, I can see the SP moving back up to 10p at least the short term