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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?
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Thanks Lambo. I missed the reference to a type C meeting with the FDA in today's RNS.

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?

Nolupus. The article you highlight does not make me wonder at all. What makes you wonder?

Pokerchips: I think many shareholders in IMM have the same question. We were incredulous that the IMM Board was handing over its much needed cash to Incanthera. The link being TM who was chairman of both companies. And what became of Sol, Incanthera's wonder suncream touted as protective against skin cancer? TM promised a big marketing deal with a major company a year or two ago. Since then, silence apart from the squeaky noise of hot air escaping a balloon.
If anyone deserves the sack, he does.

Are you sure it's a buy?

dallo: Very pertinent points you have made in your post. I think Avion will pull out all the stops to get the architecture of the Lupuzor P3 trial approved by FDA and to bring it to a successful conclusion.
Many months ago we were informed that Avion had signed up some of the leading figures in the Lupus research community in the US and had close connections with the most important Lupus patient groups there. So the groundwork has been done to ensure a successful trial.
I am expecting an announcement soon about the start of a trial of P140 (ie Lupuzor) for treating CIDP. Perhaps Avion will be involved in this as far as the US is concerned, just as in the case of Lupus.
It would be daft to exit IMM anytime soon when there are so many good indications for its future.

Nolupus: so you really expect us to believe that the Lupuzor Phase 3 trial will not begin until after 31 December 2022?

Nolupus: do you mean Financial year end? 30 June ?

draye: Good question. I think that the on-going discussions between Avion/IMM with the FDA will determine how long the Phase 3 trial will take. From Avion and IMM, there are a number of requirements that the FDA will ask for to ensure that the trial meets the FDA's standards for judging success, but how exactly will success be measured? I am not surprised that it is taking weeks rather than days for agreement on the architecture and aims of the trial to be agreed. And whatever is agreed it could make a great difference to the time taken to complete the trial and achieve a result.
It's much better to spend extra days now on these negotiations than extra months or more on the trial.

Why are the Sell prices above the Buy prices so far today?

Notaflipper: You're correct about the rock bottom sp of IMM for the past year, but the periods when price has been around 5.5p have been much more limited, and that's what I've been targeting for the past 4 months.
Have been looking again at the Lansdown deal. The nominal price of the shares they have is 11pm but the price which is used to calculate whether the full monthly instalment is received by IMM is 14.667p. calculated over a 20 day period during that month. So the first month's average share price will probably be about 6p, which works out at around 40% of the target price of 14.667p and that is the proportion of the theoretical Lansdown monthly instalment which will actually be received. Let's hope something happens to buck up the sp before the end of the month.

MaverickD: I'm so glad I bought more shares yest. on a dip. My largest holding is not yet IMM but should the price rise to a better level it will be. So hoping that the PK study will be +ve, but we've had so many disappointments I'm not taking anything for granted. If PK results are OK then we should proceed to Phase 3 Lupuzor and the start of CIDP trial. That plus +ve results of BioAMB trials should push the sp to a much higher level.

This seller provides an opportunity to accumulate more shares dirt cheap so I'm not complaining. Fully expect PK Study to be positive and for CIDP trial to begin shortly after. Dificult to prevent a price rise then.

Pokerchips:
I agree with you.
Incanthera is a strange business. We were told by Tim McC ages ago that a big deal was being agreed for marketing Sol through a major company. I guess this has not materialised and there is no other horse in the stable.

Pokerchips:

I can't really comment on the movements on the current sp. But I think you are mistaken in thinking that this is just a rerun of the couple of years leading up to 2018.
Provided the PK Study turns out to be OK then it will not only be the Phase 3 trial of Lupuzor that will start but soon after it is likely that the Phase 2/3 study of CIDP which uses the same drug as Lupuzor will also get the go-ahead and be completed before the Lupuzor Phase 3.
Moreover, there may be positive news on BioAMB in Q2. So it's a better overall situation than 2018 with more scope for positive news flow. And perhaps less pump and dump.

Michael2021 and others.
Why guesstimate the future sp? No one can tell. We have already been told by IMM that the PK Study won't be completed until the end of Q1, after which the results have to be sent to the FDA which will decide whether the end results of the Study have been met. I doubt if anyone knows how long the FDA will take to reach a decision.
So between then and now we may have a gap of around 2 months - a very long time for impatient shareholders. Some will give up and the long term holders will hold on. Some of them may add to their holdings if the sp sinks to around 5p because the potential gains will be very large if the PK Study is successful. Why sell now if one has held on for several years through thick and thin?

ShareholderACE:

You say that we are at the same stage as in 2008. I don't agree.
In 2008 we had Lupuzor and nothing else.
Now, we have Lupuzor, CIDP, BioAMB and BioCin. In the first three cases we should have significant news about their progress. CIDP and BioAMB are probably closer to commercialisation than Lupuzor. So IMM is now a 3 legged pony whereas in 2008 it was running on only one leg. The remaining leg is BioCin - hope there too but a longer wait for results.
Definitely more room for hope for a substantial rise this year in the SP.

Notaflipper:

It's only a month since Alora, the parent company of Avion, invested £1.2 in IMM. This looked to me to be an important signal that IMM's American partner in the PK Study and the Lupuzor P3 trial was seriously supportive of IMM and its science.
Pharma research is different from Bitcoin so don't expect day by day changes in outlook - and it's not about Eureka moments. Waiting until the end of March for the all-important PK Study results is not too much to ask, is it?

Some of our contributors are pleading for news from Tim to give us reassurance and to boost the SP. But if you look back to the update on the research programme that was detailed in the RNS of 18th November, 2021, it was clear that we could not expect much news until the completion of the PK Study at the end of March - so another 2 months to wait. The most we are likely to hear now is confirmation that the volunteers on the Study have all been dosed.
Beyond March, we should then hear that two very important trials have been started: Lupuzor Phase 3 and CIDP Phase 2/3. Maybe also news on BioAMB including on whether a partner has come forward to co-finance the research programme. Maybe also a similar announcement in the case of CIDP.
So, sorry to relate, this is likely to be a no-news period until the end of March. I would love to be proved wrong!