Member Info for Nolupus

My thoughts exactly…

But Avion have put some coloring to the black and white :-)

Dallo,

I think you should read the statement again
Meeting of the two companies = IMM + Avion, imo

The rabbit is out …

Dallo,

You are one stubborn person

All one can do is hope …

Tim may pull a rabbit from his hat but that may not be enough as we have seen this trick a few times already :-)

Whatever will be will be ….

" fully funded by Avion for $25m"

Not strictly correct …

Funded up to 25 million, in other words , if the P3 trial costs more well Avion will fund only 25 million

Leas,
I cannot agree with your point about the recruitment and standard of care because
1) the Mauritian patients were classed as European and they showed a higher response rate than the US cohort …

I do agree whoever that the last P3 was badly managed and was done with very limited ressources

Lambo,

What you haven’t considered , imo , is that the market has changed considerably since the last P3 ..
Benalysta has changed their mode of administration
Astra has gained approval AND
Lupuzor has signed away the US market

Even if this new P3 is given the go ahead and even if they get approval , the figures are very different …

One has to keep in mind all these considerations, whilst not forgetting the risk of failure , imo

The CIDP market is what could be the Real future for IMM imo but whatever , as always , everyone to their own point of view

Talking about what the SP could be in 2-3 years time is just a waste of time , imo

We can barely predict what the SP will be next week

And who are these ´ large shareholders ´ ??

I don’t foresee Tim being ousted :-)

Needs some positive news , Tim …

Lambo222,

You seem to be very bullish, have you bought cheaply recently ? :-)

As far as I can remember there is no SPA protocol this time round ( but I could be wrong )
The ramifications of changes in the formulation and manufacturing of Lupuzor are far ranging so I personally would not speculate on any time frame for any update .
With Imm and the FDA , one has to be patient , imv

It’s taken time because IMM and Avion have changed the formulation and CMC for Lupuzor . These things take time and every step has to be agreed with the FDA , imo

Let’s see what happens next …

1509

EVG
IQAI
IMM

I wonder why some people only come out of their cave to criticize others , whilst trying to flog their gems ?

Anyway , as usual , no constructive debate is possible.

No comments on …

The ramifications of The disclosure that there is a new proprietary synthesis of P140 ??

Hi Bojo2020

No , bogged down elsewhere for the time being

Good RNS from IQAI this morning…definitely a good long term hold , that one

Succinct

For example

As part of the regulatory process, the Investigational Medicinal Product Dossier ("IMPD") required significant revision, due to the inclusion of a new proprietary synthesis of P140, which consequently affords greater IP protection and lower cost of goods. The new IMPD was submitted to the MHRA and, following a full review, the MHRA has approved the commencement of the PK study.

There are some similarities with Lupuzor if you read through the updates

Makes one wonder ?

https://www.cellandgene.com/doc/making-an-unapprovable-drug-product-approvable-lessons-learned-0001