Immupharma Share Discussion Threads

[hamhamham1] 30/11/2017 07:26

cont..."If we’re looking ahead with confidence to the results early next year then we have to start doing those sorts of activities now such that we have the dossier ready to submit as soon as we can."

[hamhamham1] 30/11/2017 07:25

Ahh, I might have answered my own question - found this - "So, we gave that as an example in the announcement this week that we are just initiating manufacture of what we call the commercial batches of Lupuzor so to apply in the dossier, you have to have three separate batches of manufacture material which are suitable for launch. So, one has to demonstrate what the manufacturing processes are, that they’re produced to good manufacturing practice and that they are, what we call stable, in other words they have a good shelf life."

[l0ngterm] 30/11/2017 07:21

Super negative: evidence of this failed Phase trial.Please reference and provide link.otherwise it's supposition again!

[hamhamham1] 30/11/2017 07:19

So arenthry already making the drug? See this quote from the web - Decision to start to manufacture commercial batches was taken in anticipation of the trial's successful outcome and to exploit 'fast track' status'

[adejuk] 30/11/2017 06:54

the higher the anxiety, the noisier the bb

[hamhamham1] 30/11/2017 06:27

Crikey, this is a lively board - not a bad thing I guess.

[supernumerary] 30/11/2017 00:19

nt - misquoting me doesn't help your case - I never said an FDA NDA was impossible - obviously it's possible, as soon as they've completed the SPA. However that's an FDA procedure, so in the context of my earlier post it's irrelevant, because I was discussing the EMA procedure, not the FDA one. So, to summarise, you introduced something that was irrelevant, claimed I had said it was impossible (which is not true), and at no point have you ever bothered to provide evidence supporting your views.

I give up - you just say anything that comes into your head and think it constitutes rational argument. Is it just the booze, or are you always like that?

[l0ngterm] 29/11/2017 23:44

Evidence: the available body of facts or information indicating whether a belief or proposition is true or validAnd again good luck super

[l0ngterm] 29/11/2017 23:40

Super: Legal: NDA is non disclosure ( I have signed many, and set them up)Pharma: NDA is a new drug application. Read the rns etcSuper: no sense of humour (established)Now I shall rise above this and wish you well, and good luck.

[supernumerary] 29/11/2017 23:33

lt - yes, I was right. I'll take your apology as read. BTW if you actually do some research, you'll find that there was a failed Phase 2, which, while still in progress, Cephalon reclassified as a Phase 3. So Wiggy was right all along...

On to the next one.... 'an nda was impossible' ? Really? A link please. Or do you mean something other than a non-disclosure agreement?

[l0ngterm] 29/11/2017 23:11

agreed gla

[ny boy] 29/11/2017 23:10

Best thing to do is for everyone to take a long holiday until next Spring

Tiring reading the same old speculation, just wait for the Company to release further rns updates.

Meanwhile the share price will take of itself, a slow grind north to 150/175p, with odd moments of excitement until the major event.

[bermudashorts] 29/11/2017 23:08

Super - yes, I was agreeing with your translation

LOngterm - yes, although I sort of meant in the context of the overall presentation.

[l0ngterm] 29/11/2017 23:06

Super: your right it was wig at the time. Or you as wig, or you as nobby lol You as super were also stating that an nda was impossible, it wouldn't happen. Remember that? But either way provide evidence, When stating such facts please.

[supernumerary] 29/11/2017 22:54

lt - which post, which time? Got a link?

BS - 'He's simply saying that there isn't a one size fits all solution and he's right!' Exactly the translation I gave, so we all agree ;¬) Except lt, but that's to be expected...

[l0ngterm] 29/11/2017 22:52

So basically sets expectations for sufferers, great if lupuzor is successful, but it's not a silver bullet.

[l0ngterm] 29/11/2017 22:50

Bs: your are correct, this is from the organisations website, relates to the timeline 2017 summer etc. It is within the context of a de facto cure, and press stating lupuzor is a cure. WhIch IMM have never said.The link below takes you to the CNRS press release for lupuzor. Nothing sinister, at all within this context. Just super being, well not super again.Lupus Erythematosus Associationlupus?In spring 2017, lupuzor is the subject of an intense advertising campaign. Is it really the miracle drug that can "stop all lupus", as some video reports show? The press release of the FNRS in December 2015 is a bit dated, but it does a useful job of keeping the record straight. See this press release ...https://translate.googleusercontent.com/translate_c?depth=1&hl=en&nv=1&rurl=translate.google.com&sl=auto&sp=nmt4&tl=en&u=Original link:http://www.lupus-belgium.org/spip.php?rubrique54

[l0ngterm] 29/11/2017 22:44

Super: you stated phase III in your post at the time. And couldn't provide any evidence.

[bermudashorts] 29/11/2017 22:35

Guys, you have to view this video in context. I'm absolutely certain that Prof. Houssiau is a highly respected expert in his field and irrespective of any trials he has been involved with, his priority will be to bring better treatments to his patients.

The video posted here today is just a very short clip, taken out of context from a presentation and you need to listen to the whole presentation to get the overall message. In another clip from the same presentation, he talks about Benlysta (link below). The message he's trying to get across is that patients are reading about new treatments such as Benlysta on the internet and demanding to know why their rheumatologists aren't prescribing it for them. He's simply saying that there isn't a one size fits all solution and he's right! Immupharma have never claimed that Lupuzor will capture the whole SLE market but it hopefully will become another treatment option and the first non-immunosuppressive treatment ever.

[supernumerary] 29/11/2017 22:18

How did you know it was a Phase 3? lol

For those who haven't been drinking... I queried Lisa Baderoon about IMM's involvement in the EMA PRIME scheme. Her response was:

'This is something currently under consideration through our own CRO
Not much more I can add at the moment'

At the time, I didn't know what drugs had been accepted on PRIME but later discovered a spreadsheet that gave those that had been approved. Lupuzor was obviously not amongst them and as far as I can tell from public records, no approach has yet been made to the EMA by IMM.

As the EMA describes PRIME as the runway to accelerated approval, it seems to me that IMM should get started as soon as possible. Given the planned transfer of EMA to Amsterdam and the disruption that will cause, interaction with the EMA is likely to be slower and slower over the next year or two - delay could end up being severely punished.

[l0ngterm] 29/11/2017 22:17

Sorry folks, for clarity we have been round the houses with super before.I shall await his evidence on the trial he keeps mentioning, and sit in quiet contemplationGla..

[fidra] 29/11/2017 22:08

Edited .i do believe the date .not sure why he is not up to date on the study ,if he is such an expert .if he works for the competition that is probably why .

[l0ngterm] 29/11/2017 22:07

Can't can you? Nope.. nothing.. zilch.. zero.. zip.. Nana..Thought so..

[l0ngterm] 29/11/2017 22:05

Super: again, please provide evidence of this imaginary phase III trial..Go on..

[supernumerary] 29/11/2017 22:02

dave - it also failed a trial, the results for which have never been released. There's scope for a lot of interpretation here.

lt - I gave the date - May 2017, so I've no idea what you're on about with 'early stage'. As for 'lighten up' - I do find it amusing that you're happy to traduce a respectable researcher on the basis of a 2-minute video that you literally cannot understand.