Immupharma Share Discussion Threads

[pre] 10/11/2020 08:46

really? this is on the cusp of getting FDA approval for Lupuzor in a matter of weeks rather than months imv.

[justtrying1] 10/11/2020 08:38

Will be months before any anawer take ya profits while u can

[halfbutt] 10/11/2020 08:29

Stand back...I. not sure how big this thing gets.....

[daveboy1] 10/11/2020 08:16

Yep, he's certainly no magic mushroom.

[nobbygnome] 10/11/2020 07:41

Well that is astonishing news if it indeed happens. The FDA would not normally do such a conditional approval but it looks like it is possible. Somewhat surprising but good for IMM if it happens.

[joeblogg2] 10/11/2020 07:36

With covid fda granting approvals left right and centre and Lupizor is well tolerated!!!!

[divmad] 10/11/2020 07:32

Potentially very good news? Not long to wait now then. 30 days until the FDA guidance meeting. Then the possibility of conditional approval for marketing whilst the new Phase 3 trial is underway.

[brad44] 10/11/2020 07:29

Up yours chungy!!!!!!

[ken chung] 09/11/2020 22:15

What a pile of rubbish this is.In other words a fine short.Lemmings and mushrooms only.

[parc1] 07/11/2020 15:31

Background to agreement with Avion

"Further data analysis, reported on 29 May 2018 demonstrated that in the European cohort (130 patients) Lupuzor(TM) plus standard of care ("Active Group") showed statistically significant reductions (71.1 percent vs 48.8 percent, p=0.0218) in disease activity compared to placebo plus standard of care ("Comparator Group") in 79 patients (60.8 percent) who were anti-dsDNA autoantibody positive ("Antibody Positive")."

Looks far better than p 0.05 and Immupharma and Avion have identified a new optimised Phase III clinical trial design.

[nobbygnome] 07/11/2020 09:26

Great find. It is reassuring to see that the anecdotal views in the industry have been confirmed!

[parc1] 07/11/2020 09:22

Avion has studied the findings in detail and formed their opinion, providing $25million for the phase 3 trial.

They have all of the data from the trials.

In an ACR study on Placebo effect (in rheumatoid arthritis med trials) this was mentioned "Non-Western location was a statistically significant factor that contributed to placebo responses".

[nobbygnome] 06/11/2020 22:22

>> sk

For the anti DNA positive patients that was true but was it for the whole group? And you don't know the breakdown between the Mauritian and European patients. Unless we see the breakdown it is difficult to come to any firm conclusions.

[sicilian_kan] 06/11/2020 22:09

Actually Nobby the best results were in the European / Mauritian arm.

[parc1] 06/11/2020 20:48

Well I hope they have picked up on Mauritius patients. That is a great point you have made. The trial either needs better efficacy or lower placebo response and perhaps they will achieve both.

[nobbygnome] 06/11/2020 20:29

>> parc1

But Avion have no experience in lupus or even rheumatology!

[nobbygnome] 06/11/2020 20:23

Yes having a lot of patients in Mauritius was a basic error IMHO. In countries like that they don't have access to the best healthcare so you tend to get a high placebo response because they are desperate for it to work; it is a well known phenomenon in the industry. And what happened in the trial...there was a high placebo response!

[supernumerary] 06/11/2020 20:04

I don't think IMM can do it - they don't have the staff or the skills - either they or Avion (most likely) will have to use a CRO.

[parc1] 06/11/2020 19:57

I think Avion's funding will help for an effective recruitment campaign and it should help having a US company involved for patients in US.

Yes, Avion don't have trial experience so up to Immupharma to control it. I think Avion's initial use (apart from the cash) is help with contacts, physicians for patient recruitment. It is a competitive area and any help is good.

[supernumerary] 06/11/2020 19:53

We crossed.

But would the lupus nephritis patients be excluded, thus limiting the frequency?

EDIT: I like the idea of an anti-Smith antibody - they could have used that in The Matrix :)

[supernumerary] 06/11/2020 19:51

Not sure I really understand this: - see table 1, but 60-90% seems possible - better than I'd imagined.

It may be population dependent of course - I seem to remember they recruited a lot of the last cohort from Mauritius? - so they could have a rather specific genetic profile.

I think we really need to await further information about the trial.

[nobbygnome] 06/11/2020 19:45

Just looked it up and it appears I am wrong; it is only 30% of the patients!

[nobbygnome] 06/11/2020 19:42

From memory it is 60% of the patients but am happy to be corrected on that. So clearly they are shooting for a smaller patient pool.

[supernumerary] 06/11/2020 19:37

I was just asking myself what had changed to the last trial, and of course it's that they're being more selective about patients - as I understand it, they're now only recruiting patients who test positive for anti-dsDNA autoantibodies. I don't know how common that is, but it will surely be a big factor in the rate of recruitment. I remain dubious about the whole trial, but am happy to watch and wait.