Member Info for Nolupus

Hopefully no RNS tomorrow Halfbutt ..

Frits likes Tim’s sauces with his fish&chips but I think that is very indigestible tbh

Halfbutt,

Hopefully things will sort themselves out and you and your wife will be able to afford to take a coffee with Eva in Malta :-)

Send the bill to Tim …

Take a break and have a KitKat …

The buyers are lining up but it will take time .

Hold for gold is my opinion but it will probably take months rather than weeks !

Notaflipper,

I don’t believe that Avion will pull the plug on the P140 program or that the FDA has shafted anyone !
Let’s wait and see what will be decided by IMM and Avion but I am also fairly sure that the directors won’t lose any money, no matter what happens ..

Whatever will be , will be

When the science is good and validated, it’s only a matter of waiting for the market to acknowledge the progress and the potential, imo

Patience is needed whilst investing in biotechs

Solid !

Cuvio,

Whilst this study is on a relatively small number of patients and is still in the earlier stages , it might prove effective in younger patients it remains to be seen how / if effective on the major proportion of Lupus sufferers, I.e. the 25-50 group

Hi Hold4results ,

I presume that you are talking about this ?

https://www.nature.com/articles/s41591-022-02017-5

Easyp,

You should post more often:-)

Cuvio,

Good points !

We were only informed of the changes to the IMPD , in February 2022 , in a very succinct way , so it’s all speculation as to the changes ..
The FDA had previously requested the PK study which was highly surprising for a P3 candidate …

We will just have to wait and find out what exactly this entails for Lupuzor and the P140 program but it must be said that IMM communications are extremely confusing as Nothing is black or White so therefore open to interpretations which can be erroneous or not …

Lambo222,

Whilst all this maybe very disappointing for IMM shareholders, it has been very much anticipated by Avion and IMM, imho ….
The FDA has not, imo , done anything to block Lupuzor moving forward in the sense that it was IMM and Avion who decided to change the formulation /CMC of Lupuzor.

The FDA are just doing their job ….

Lambo222,

The likelihood that Avion will continue to support Lupuzor is very high, imo
But there might be a price to be paid for that support , unless Tim has other options up his sleeve ?

Let’s wait and see how the negotiations work out ..As once again I think that all of this has already been anticipated by all concerned

Cuvio,

It is indeed a fascinating subject on how everyone can interpret differently the same RNS .
We have all got our own biases and therefore our interpretations will not be fully objective , imo
Only time will tell which biais is correct but with a bit knowledge , a bit of common sense and observational skills one can reach such a biais , be it right or wrong :-)

No matter what the outcome , I still think that a step back , before moving forward is the best road for potential success.

Whatever will be , will be

Cuvio,

I have to agree with LLL and the most telling thing for me in the RNS was this …but you can interpret ist differently to me , of course

This included advice on the dosing regime.…

That does suggest that they have advised a P2 , to me …

Cuvio ,

We are saying the same things yet we interpret them differently…

The FDA gives guidance and advice until you ask them for market approval , when they pass judgement.

Today’s RNS implies that the FDA has ADVISED them to review their copy ….and on how to do it , imo

Dallo,
So it is all about the guidance given and requirements/ protocols sought by the FDA in its written response.

Exactly , The FDA don’t refuse a trial , they ADVISE you , that they think your proposed trial is conform, or not with their expectations for market approval. They advise you , they don’t tell you …

Looking forward to the presentation !

Notaflipper,

If one looks objectively at the last placing , you might find some evidence of the expectation…
Whatever

LLL,

I think we should be objective,..the P3 may be delayed, whilst doing further regulatory trials , it certainly does’nt mean that this is a dead duck .
One has to remember that if IMM had not changed their formulation, we would probably be halfway through a P3 trial at this time so therefore Avion must have estimated that it was in everyone’s best interests going forward to implement the changes !

All in my opinion, as per usual

Hi Trek,

This was totally expected by IMM and Avion, imo
They changed the formulation and CMC for Lupuzor and therefore they should have known that the FDA would call for more clinical appraisals of the new product . The PK trial was the giveaway..
Now after stating that , I would state that this situation was anticipated so therefore we should see a follow up RNS , on how Avion will proceed and the risk/reward for a PUNT is extremely tempting, imo