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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 ?
As there is a reasonable prospect of Lupuzor showing success against the placebo group, FDA approval for phase 3 trial is highly likely: odds are about 10/4 on.
My opinion only.
Will be 8p by the end of this week imo as people begin to take positions, many people forget this company was £250m Mcap and well over £100m Mcap for the majority of the last phase 3 trial, Avion want to see Lupozor as their lead product in the US… Avion is owned by billionaire US investors… if they start to take a position in little old IMM once we get FDA approval the rise here will be something very special indeed, won’t take much to push this up to £100m Mcap a 5 bagger from current levels and it would still look cheap as we do partnering deals for rest of world rights and also the phase 3 in CIDP trial, exciting times ahead
Getting some traction.
Double figures expected should they get drug to phase 3.
Big week ahead, defining few days in the history of this company, think this explodes on FDA approval as many are waiting in the sidelines, high risk high reward but think this does 200% on approval, GL all we are in for quite a ride over the next few days, 20p possible intraday imo
Maestro
The only things that are certain in life are death and taxes .
As a very longterm and large holder in Immupharma I am always nervous before a major
crossroad as disappointment has been a constant companion over the years in this investment.
We will be delighted if we get good news from the FDA but finger nails will be bitten until we do so.
ATB
There’s not even close to £1m to flip either, there was £950k placing, £100k went to bod, friend of mine took £50k so that’s only £800k, a lot of that will have been long term holders reducing their averages, I know you took a few Dallo? £700k volume this week which is huge for IMM so I reckon we will have shaken off the loose hands by early next week! And a lot of people will wait for the FDA decision on the 29th, 5 trading days to go, I personally think we see this move towards 7p next week ahead of news, positive and it’s 15p all day long imo
dallo
£1m placing, not many to flip.
why are people getting nervous, they could have commenced phase 3 last year but FDA asked for PK study which was successful, its just the official go ahead now.
Maestro
You could be right but we have to get rid of loose holders at 5p before we move higher.
It all depends on the influx of big investors willing to stay longer term .
I think if the FDA approves then these big punters will take out the short term investors very quickly but all conjecture at the moment.
Nervous times ahead next week but fingers crossed.
ATB
dallo
When they announced the PK study back in april IMM went in double figures, the PK test was needed for phase 3 trials, i think there is some placing churn going on, good thing is its small, £1m is not huge.
Once IMM drug gets back to phase 3 i think there will be rerate.
two comparative companies with phase 3 product are valued at £57m and £111m, with avion doing all the hard work and IMM fully funded for at least 1 year, i see this rerating to double figures when fda approves phase 3 trials.
Ive previously been in shares ive become not happy with instead of moaning constantly about negatives sell up move on. I bought in here before and sold long time ago bought back in only because of Avion theyre going to take this forward lucky enough for Imm think far more profesional. Tim talks a good game with promises but Avion will deliver
Wig
I agree we may not get the initial uplift in the SP if the FDA approves the Phase 3 but Immupharma will be a great position going forward and may progress through partners the development of its other peptide drugs and do a deal on the rest of the world Lupuzor rights.
Immupharma will not develop or progress the other therapies on its own , it will never have sufficient resources so it will do an Alora type deal imho.
Or even more likely agree a sale to a larger Pharma for the whole shop...maybe Alora but plenty of players may be interested.
All depends on the FDA next week
Fingers crossed ??
Unfortunately, the FDA and not Avion decide which drugs get approved, and they haven’t seen enough evidence yet. 5+ upticks suggests a lot of hot air already built into price, one wonders whether trial approval will be a damp squib :(
Fortunately documentation from previous trial will be on record all information and based on that Avion must be convinced by their expertise scientists going over it. Theyre happy then i'm happy theyre the ones ploughing in millions to make it a success
Lol maestro. Unfortunately the FDA require more than TM’s speel as proof that Lupuzor works :)
And there in lays the success this time round. Rest of World Market ..... looks good only need go ahead from FDA in over weeks time
Yep your right Maestro the drug was a big success on those patients with bio markers and this time around only patients with the bio marker will take part in the trial! If we get the FDA approval we could be onto something very special here, tiny Mcap and billion $ sales potential annually, CEO predicts profits of $150m from royalties annually, can you imagine the Mcap if we get to them levels and that’s just US sales alone! Next week I full expect this to push towards 8p ahead of news
Wigwammer
You clearly havent done research, they did trials in europe and usa, in europe 2/3 were patients with biomarkers present and in usa 1/3 of patients had biomarkers present.
The conclusion was the drug worked on those with the biomarkers.
Hopefully this should now start to move.
So only those with biomarkers present will be in phase 3.
So it works.
Well hopefully it follows the same pattern as AZN Approved Lupus drug, passed the second phase 3 trial, gained FDA approval and all in a short space of time,life changing gains on offer here for those of us in early sub 6p could easily be worth 60p if we get FDA approval and another partner deal for the ROW rights, then we have CIDP trial and all the other indications for a Lupozor, think we will have a big week here next week as people start to take positions… only 5 trading days left to get in before news after today, GL all
“The drug works” says maestro1. Erm - think they need to prove that in a ph3 trial first :)
Two comparable biotech companies with phase 3 assets are worth between 57m to 111m, here we are at 20m.
On the pk study in april this did 100% now once fda is approved on 29th aug i can see it doing again. The drug works.
Spot on game changer and thats why Avion are sticking with it ! They will have gone through meticulously all the detail on previous trial and if your daft enough to believe they would throw $25 million into something not confidant in you must be bonkers. So bring it on worldwide rights will take that please
Lupus is a chronic inflammatory disease which is thought to affect some 5 million individuals worldwide. The current standard of care still consists of drugs which have many side-effects and limited efficacy. Despite the need for an effective treatment, only two therapies, namely GlaxoSmithKline's Benlysta and more recently, Astra Zeneca's Saphnelo, have been approved to treat the condition over the past 50 years. As such, there clearly exists an unmet medical need for a drug that has a strong efficacy and safety profile.
The lead program, Lupuzor™, is a first-in class autophagy immunomodulator which is in Phase 3 for the treatment of lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action.
Its not only Lupus, if this mechaniism of action works, we have a game changer regards other autoimmune diseases that share the same autophagy mechanism of action.
We may not have the rights to the US if this goes to plan, but we do have the rights to the mechanisim of action and the rest of the world!
Its a no brainer, all we need to do, is get the Phase III trial managed correctly this time.
Frits