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Marstro1,
You have your opinion which differs from mine but please don’t be offended if I stick to mine :-)
Nothing is guaranteed so it’s just a matter of odds so everyone has to calculate theirs
Nolupus
The ceo said they had permission from fda last year, they could have technically started it then. But they asked for pk study which they didnt last time, they could have started without pk study bit they didnt want to offend the "gatekeepers".
Remember Avion are running the show now, they have got 3 drugs through fda so they know what they are doing.
Clearly the drug work effectively with patients who have biomarker ie mid to late stage lupus. It was only that in the usa study only 1/3 of patients had the biomarkers had it been 2/3 patients with biomarker who knows they may have been approved.
Avion have looked at all the data they are taking the risk they know its a great drug..
Maestro1,
Am I annoying the pump&dump crowd so much ?
Sorry for being so contrarian and my ´head master ‘ Style attitude but it’s still the FDA that decides things about clinical trials and protocols and nobody else.
If the FDA are not satisfied with the ´new ´ Lupuzor , they could refuse a P3 trial and ask for some other trials , is my view but whatever , we shall soon know
Nolupus
Dont know what your agenda is here, probably old disgruntled shareholder who knows.
The ceo clearly said they had phase 3 permission last year but fda asked for pk study they could have started without the pk study but one wouldnt want to annoy the "gatekeepers", his words.
As the PK study was successful, phase 3 will go ahead now..
i'm 17p to break even. This tick up pre FDA new is nice
Yes FDA confirmed they will be providing their written response on 29th August, so I assume meetings are taking place this week at the FDA, if the US pharma investors start to the positions here we could be onto something a bit special… Avion backed by billionaire investors and Avion see Lupozor as their lead product due to its potential for multi billion $ sales in the US
TOP 3 ON THE RISERS BOARD....News has to come by next Tuesday by the rules..
More rises to come..
MASSIVE TRANFORMATIONAL NEWS ANYTIME..
I will top slice at 9 pence...then hold the rest.....
Over £1m traded in the last week…. That’s huge for a tiny company like IMM, will continue to build this week ahead of company making announcement on 29th, think we will be 8-10p Friday morning easily
Huge.....? Mrs Lambo must be pirennially disappointed if you think thats huge!
Felt like telling all those poor folk on CINE to buy IMM and they can make back their losses really fast.
As with all binary trades , one can make money or lose money …
Two sides to the coin , so whatever will be , will be
Huge buys coming in now, could be some huge money to be made here over the next week
big money.
CEO predicts $150m a year in royalties from the US alone… the billionaire investors who back Avion could well make an investment in IMM once we get FDA approval… 4 trading days left until news, FDA will be having their meetings early this week imo with meeting minutes typed up end of week and sent to Avion and IMM on 29th August via written response, could be a big story about to unfold here imo 15-20p daily possible on approval imo
up we go
GSK just had Benlysta approved
Lupuzor has no safety concerns, approval for P3 on Monday
Lupuzor™ is expected to be less expensive than GlaxoSmithKline’s Benlysta, the only drug that has been approved in over 50 years, which currently costs patients around $25,000 a year
Supermobileman,
If IMM had’nt changed anything in the Lupuzor formulation etc , you would of course be right . The FDA would have allowed the new P3 with IMM excluding all patients not having the bio marker , imo
I still don't believe people here are still contemplating whether FDA would approve phase 3 or not.
What is it that you lot don't understand?
After the first inconclusive phase 3 trial, IMM held talks with the FDA and the FDA gave authority another phase 3 would be allowed pending design protocol.
On this account, Avion signed a licensing deal with IMM to take and fund Lupuzor into second phase 3 trial
Numerous RNS state Avion will take and fund phase 3. Nowhere does it state "if FDA approve phase 3, Avion will fund future phase 3".
Goggles,
The FDA won’t be influenced by presumed odds of efficacy in endorsing this new P3 .
After changing the Lupuzor formulation and CMC criteria , all that really matters now to the FDA , imo,
Has IMM ticked all the equivalency boxes ?
Is the new criteria for this new P3 , compatible with the FDA guidelines on Lupus trials ?
something is happening...
Only 4 trading days to go before FDA decision… Monday is bank holiday so news Tuesday imo could be blockbuster it’s been a while since sim had a 200% riser, think this did 300% when they first announced the Avion deal
IS THIS GOING TO RIP UP FAST?
Could be big jump in prospects on approval. Anyday now.