Immupharma Share Discussion Threads

[nobbygnome] 04/5/2022 16:29

It's time to admit you are wrong, pwhite. It's really not that difficult.....

As you say another spike killed no doubt by Lanstead

[pwhite73] 04/5/2022 16:02

Contrary to the RNS statements I don't believe IMM are still involved in the development of Lupuzor and this is why its going to be a major success. Avion are bearing the entire cost of the international Phase III study. They have also received strong indications from the FDA that the drug will be approved perhaps even before the end of the Phase III trial. They don't want IMM fking things up like last time. This is why I believe they are keeping the PK data close to their chests despite the agreement stating all clinical data will be shared.

IMM have been relegated to funding the directors wages by a death spiral Share Agreement. This is what is wiping out all share gains. Shareholders have to await general news Avion offers to IMM. That's my take on what's happening and in the long run its good for PIs who are prepared to bottom drawer the share.

[supernumerary] 04/5/2022 15:56

Obviously they have the results.

Wasn't there an inverse dose correlation shown at one time? That seems the most likely area of investigation for the PK study to me.

[nobbygnome] 04/5/2022 14:32

So let's think about this. IMM are planning to do another study with IMM in a different indication but are going ahead planning that without knowing the details of the PK study which are going to be critical.


It's IMM's drug FFS so they have the right to get the results.....

[nobbygnome] 04/5/2022 14:30

Trust me, they will DEFINITELY know the results!

[pwhite73] 04/5/2022 14:27

The joint committee has been set up to progress the Phase III trial. The Phase III trial is an international trial so IMM would be involved in the recruitment process probably in the UK and France. The RNS then goes onto say:-

"ImmuPharma will provide an update on the progress of the PK study once it has commenced."

That's exactly what IMM have been doing giving updates on the progress. I very much doubt IMM knows what the results of the PK study are suffice to say they are to the satisfaction of the FDA.

[nobbygnome] 04/5/2022 14:17

There is a joint steering committee (see RNS link below) so it would be extraordinary if IMM didn't know the results. I have been involved personally in these sorts of collaborations and the data would always be shared!

[pwhite73] 04/5/2022 14:06

Avion through the license agreement are now conducting the study into Lupuzor with funding available of up to $25 million. It is highly unlikely the management at IMM would know what the PK study results were as they are no longer involved in the development of Lupuzor. Avion would be forwarding IMM management only general information for the purpose of complying with listing regulations.

[arlington chetwynd talbott] 04/5/2022 13:53

I guess that if the market had that information and it appeared satisfactory you would not be getting your shares at anything like the current price!

[mudbath] 04/5/2022 13:38

Just to be clear I too could be a big buyer here if only I had the cash.

[nobbygnome] 04/5/2022 13:05

I want to know what the 'positive readout' from the PK study was. Why won't the management give us the numbers and also tell us why the FDA asked for the study? That would be the only way to fully understand what is going on. McCarthy like putting out lots of RNSs but they rarely contain anything of substance.

Just to be clear I could be a big buyer here if I had that information and it appeared satisfactory.

[arlington chetwynd talbott] 04/5/2022 13:00

I should hope so too. I would guess that most folk on here are waiting for the Phase 3 RNS. I doubt if many are planning to hold right through the study for the result.

[pwhite73] 04/5/2022 12:46

The RNS was in part to cushion the blow of the death spiral used to fund the non-Lupuzor part of the company. However that Avion are seeking final guidance of the Phase 3 study is good news. They are not marching forward until the FDA has ticked all the boxes.

[arlington chetwynd talbott] 04/5/2022 10:55

Absolutely. That will be a spike worth waiting for!

[tomboyb] 04/5/2022 10:54

Nobby I agree -

Re-reading that RNS although good news, its not new news is it? -

Final Guidance from FDA still sought which I though was happening as per RNS prior -

[nobbygnome] 04/5/2022 10:50

Indeed and I know more about that history than most! Actually reading the RNS again you have to wonder what the point of it was as it actually doesn't really add any more to the last one. As you say the market will only really believe it when they see the RNS that the phase III actually goes ahead!

[arlington chetwynd talbott] 04/5/2022 10:45

Given the history here, of course it is sceptical!

[nobbygnome] 04/5/2022 10:30

So the market still seems sceptical about the phase III which I am actually surprised about. Ho hum.....

[arlington chetwynd talbott] 04/5/2022 10:26

Phase 3 proper required for a spike, I think.

[photon] 04/5/2022 08:18

Risk/reward looking interesting here now. Also interesting is Avion's approach to precision dosing with their Dhivy product. Simple but smart and patient-focused.

[tomboyb] 04/5/2022 07:43

Gonna be an interesting day ahead -

Big up for BIOTECH -

[pwhite73] 04/5/2022 07:42

The RNS reads to me like Avion have requested Lupuzor be part of an Accelerated Approval Program. There has been only one approved lupus drug in 60 years Benlysta but it has severe side effects. Lupuzor could be on the market before the end of the Phase III trials as it has demonstrated no side effects.



"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval."

[1bond] 04/5/2022 07:41

Why wouldn't Avion seek FDA final guidance? It would be foolish to press-ahead without involving them !!!

[david gruen] 04/5/2022 07:23

Appreciate the balance returning to your posts Nobby.

[nobbygnome] 04/5/2022 07:21

So good news that apparently the phase III is going ahead although Avion are still requesting 'final guidance' from the FDA on phase III trial design. Spike coming up today