Immupharma Share Discussion Threads

[the stinger] 12/8/2021 14:55

Sells incoming..

[scrabster1] 12/8/2021 14:47

Nobby knows his onions.

[the stinger] 12/8/2021 14:45

750k short now, will buy back at 5p.

[harleydocman] 12/8/2021 14:38

Nobby,

With a probable 2022 starting date for this PIII ( IF the FDA are happy to give the go ahead after this P1 trial ) that would give a 2025 readout would’nt it ?

How many years will be left on the Lupuzor patent ? not many if my memory is correct .

[on target] 12/8/2021 14:25

The PK is clearly to address exactly what Nobbygnome has been calling to be addressed i.e. the dose not being high enough. But he's still not happy!

They might have tried 1mg and had too many side effects, but the dose used in the previous P3 - that did have a clear efficacy over the placebo just not enough to cross the line - was just 0.1mg (if I recall correctly). So what about 0.2mg or even 0.15mg etc??

Just a relatively small increase in efficacy than the previous P3 trial would be as good as or better than the drug recently approved for SLE which was posted on here earlier in the week.

[nobbygnome] 12/8/2021 14:13

Flávio is correct that I am positive on the drug; it has a reasonable chance of working if used at an appropriate dose.

And it can't be a phase II because there is no efficacy readout. I stick by my 6 month estimate because you have to factor in FDA assessment of the report. That never happens quickly.....

[the stinger] 12/8/2021 14:11

Your all deluded on here.... this BOD will continue to disappoint... you were warned!

[the stinger] 12/8/2021 14:08

Next raise here at 5p...

[eva_1989] 12/8/2021 14:05

My first filter..

Feeling good!

the stinger12 Aug '21 - 13:22 - 37287 of 37289 (Filtered)

[eva_1989] 12/8/2021 14:00

Col - I did quick google and it seems FDA never rejected any PK in the past. But they ask for some amendments if needed.

I’m now starting to think this PK as Phase 2 trial.

Should PK is a success ( which it should ) then it should generate feel good factor here.

P3 is a different beast and could take 1/1.5 years.

[colsmith] 12/8/2021 13:53

Nothing really to say now for 'N' months but it seems from 9th February 2021 RNS (2nd para below)that the PK study is part of the P3 trial - so P3 started? there again 1st para below says - "prior to commencement of P3" FDA sure like confusion. Anyhow over and out until the next RNS. Question is - does the FDA strange handling timescale mean they believe its more likely than not it will succeed?

Extract from link of 9th February--

In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic ("PK") characterizations of Lupuzor(TM), prior to commencement of the Phase 3 trial.

A final guidance meeting between Avion and the FDA is being planned at which Avion will submit the methodology for assessing PK as part of the Phase 3 trial. This meeting, which is expected to take place in Q2, will also confirm previous submissions to FDA on the study design, clinical end points and approval process.

[the stinger] 12/8/2021 13:22

Short this dog..

[eva_1989] 12/8/2021 13:17

Target -

In this case for the PK study it's healthy men though i.e. basically the majority of the male population under 50, and they need 24 of them.

— Aah I didn’t know that!!! Many thanks for clarifying: this is good then...

Harley - if I offload my 1.2% holding then share price will crash. I didn’t sell and no intention to sell till I get my 16 or 20p level.

Super - Valid points. On the other hand, should PK find success then share should rally in the anticipation of successful P3 trial.

[supernumerary] 12/8/2021 13:00

It's obviously going to take 6 months or so for the whole process, but it shouldn't be expensive to run - it's just the cost of keeping the ship on the road for longer that eats money.

I still think the key is the nature of the checkpoint at the end of the study. Will the FDA stop the whole thing if they don't like the outcome? Will they impose further conditions on the P3? Or is it just part of the information-gathering process and of no immediate decision-making consequence?

We need to see the trial definition.

[amaretto1] 12/8/2021 12:56

Were is Scilian Kahn ?

[the stinger] 12/8/2021 12:45

1ultimate-loser

[flavio_monteiro] 12/8/2021 12:23

Eva_1989..Nobby is not negative on Lupuzor...he thinks it a good drug..he has always doubted the dose that ImmuPharma have chosen to use!

[harleydocman] 12/8/2021 12:22

Eva_1989,

Easy to see that you sold out this morning !

[on target] 12/8/2021 12:16

eva, yes recruitment for the later trials where they can only take people with the disease along with various other conditions/exclusions is always more difficult and can take longer.

In this case for the PK study it's healthy men though i.e. basically the majority of the male population under 50, and they need 24 of them.

[eva_1989] 12/8/2021 12:14

Flavio - at the end of the day, trader and investor do whatever they think right/wrong.

I also didn’t hear Nobby advice and here we are.

Point is one negative view is fine but clogging the board with constant negative thoughts is just too much.

Again, at the end of the day everyone will do what they think is right. This is what it is..

[flavio_monteiro] 12/8/2021 12:02

Nobby has worked in the Big Pharma field of Lupus trials...he knows his stuff.

I still regret not taking his advise seriously 5-6 years ago!

[eva_1989] 12/8/2021 11:57

Target - From what I have learned from different pharma companies is that recruitment is always a headache.

Let’s be more conservative and think about this scenario.

Recruitment 1 month
PK commence following recruitment 3 months
Submitting data back to FDA and awaiting responses - 1 month

So I think minimum we have to wait is 4 months and that’s very conservative estimate.

But with IMM add extra couple of months so that’s 6.

Now my real worry is funding..

They have to raise by 2022 end so any share price appreciation will be under pressure.

I believe we will see fund raising before P3. Tim is cunning and he will take advantage of P3 approval should happen.

And most important question who will find this PK ?! Avion ?

Sorry my post seems negative but I learned today’s RNS is no good and add misery to our long waiting game.

Now I wish I would not have enter here as money seems stuck now again for 6+ months.

Rant over!

[lord loads of lolly] 12/8/2021 11:52

nobbygnome - I don't deny your relevant knowledge in this area. But I still seriously question your motives. Why on earth would you spend so much of your waking life regularly posting about a share you've nothing invested in? It just doesn't add up. And before you ask, I am a holder in IMM which is why I post here from time to time.

[on target] 12/8/2021 11:42

You think there's a shortage of healthy men eva?

Recruitment of 24 young healthy men will be rapid - they'll just offer a few £k (or a few $1k) to some uni students and the like. Probably already a bank of them waiting for trials.

[nobbygnome] 12/8/2021 11:27

It's a good point about at least a 6 month delay. If the trial takes 12 weeks from when it starts (which won't be tomorrow), that's 3 months gone. Then they have to write and sign off the report which will take a month. Then the FDA have to assess it and then (hopefully) approve the phase III. I doubt that will take less than two months and maybe considerably more. So you have to anticipate earliest start for the phase III is Q2 next year.