Immupharma Share Discussion Threads

[nobbygnome] 15/5/2018 14:08

>> Francis

I have never claimed to be a statistician but I know enough to get by. How much do you know about PK, drug levels and cell biology? That is my expert field.

I have enough experience of the industry to know that a drug which gets a p value of nearly 0.3 will not get approved. No amount of post hoc analysis will persuade any regulator and if by any chance they opened the door, GSK's lawyers would be all over it like a rash, which is why it won't happen.

Nobby

[francisgalton] 15/5/2018 14:03

For Nobby gnome

If I toss a coin four times and it lands on heads every time, I have not reached statistical significance to prove that it is not a fair coin. But that does not entitle me to conclude that the four consecutive heads were tossed by chance. The trial was underpowered and actually meant I could reach no firm conclusion at all.

Regarding your complaint, you are actually continuing to prove my point for me.

[mingbat] 15/5/2018 14:01

Nobbygnome has consistently refused to accept that failure to prove the positive does not equate to proof of the negative, despite having the logical fallacy pointed out to him on more than one occasion. I doubt he will start now. His continued conflation of two very different statuses only demonstrates an intention to mislead imo.

I do not argue that all is rosy in the IMM garden - it clearly is not, but I am tired of seeing him repeat nonsense that the trial "proved" that Lupuzor is no better than placebo - it did no such thing, it simply didn't prove at generally accepted level of statistical significance that it was better.

[nobbygnome] 15/5/2018 13:59

>> rns

Previously I would have been one of the Pharma people doing the due diligence so I think I know what I am talking about. LOL.

As I think I have said before, I have 34 years experience in this exact field.

Nobby

[nobbygnome] 15/5/2018 13:56

>> Francis

LOL. The result tells you that it was not significant and was by chance. So next time you have no idea what the result will be. The p value may be 0.2 that time.

I wouldnt be so rude as to question your credentials...

Nobby

[francisgalton] 15/5/2018 13:35

For Nobby gnome

Statistical significance required in this case that there be only a 5% chance that the outcome was down to chance.

If I prove that there is a 91% chance of the drug working in anti-dsDNA patients and only a 9% chance that the result was attributable to chance, that does not entitle me to conclude that the drug does not work. Such a conclusion is logically bankrupt.

It is quite possible for this outcome in a trial of this size to be as a result of an underpowered trial with the wrong entry criteria. Not by much though as only 200 patients in total would have been enough to reduce the 9% chance to a sub 5% chance with similar results.

This puts me in a quandary.

On the one hand you clearly have a lot of experience.

On the other hand your understanding of statistics is so fundamentally flawed that I question your ability to reach a rational conclusion. Which opens everything else you might say open for challenge too.

[rnsday] 15/5/2018 13:33

Haha have you heard yourself (pharma will analyses the date in the same way as me)....it's nothing to do with the drug you just love yourself pmsl 😂😂....you are just a bb keyboard warrior 😂

[nobbygnome] 15/5/2018 13:06

>> Francis

Pharma will analyses the data in the same way as me and come to the conclusion it is just too risky to invest in a drug which has proved at this dose or higher that it doesn't work. Reformulation and proper dosing is the only way forward. Of course IMM could raise £25 million at say 15p and do the trial themselves. Not sure they would get many taker to put up cash though (except che of course!).

Nobby

[che7win] 15/5/2018 13:00

Think of it this way, a pharma can do a JV deal and get access to P140 platform. Or do a takeover.In two years time, they could be selling the drug and making a six figure profit rising to billions in 10 years time.That is exciting, at this price there is a big anomaly.Think about it, this is a very interesting situation.

[francisgalton] 15/5/2018 12:38

For Nobby gnome

There is more than one way to skin a cat.

Get an amended SPA for the anti-dsDNA patients to guarantee approval if the trial is passed. Then run a short 300 patient Phase 3 trial to prove up the anti-dsDNA results indicated in the first Phase 3. Cost £12m. Time to run trial just 2 years. Nice opportunity for a pharma too.

Spending £100m is just not needed.

In the background they can reformulate in case and to extend patent life if possible. But no need to throw the baby out with the bath water.

[che7win] 15/5/2018 12:36

If you think the FDA passed Benlysta with all those side effects and low efficacy, many patients not able to take it.

Then think about Lupuzor. It works, even if we look at the full remission, with no risk to the patient.

The thing is, there are a lot of patients for which Benlysta either doesn't work or the side-effect profile makes is unbearable to take.

Lupuzor is being requested by patients, that is because it is the first specific and non-immunosuppressant therapy for lupus.

For the sake of patients, it will get to market.

[che7win] 15/5/2018 12:32

Divine,
I see your post earlier, I agree.

I think we have:

1. proved this drug is completely safe
2. shown it can provide complete and full remission for some patients.

I think they should be more vocal on this, the P140 platform now opens out to all the other uses, completely safe and no need for earlier phase trials.

[che7win] 15/5/2018 12:27

The dosage is correct, the piggy works.

It's efficacious at this level and completely safe of course.

Phase IIb and Phase 3 show they got the dosage level spot on, you don't get such a good result in Phase IIb for this dosage by chance.
You don't get complete remission in some active patients phase III by chance versus none in placebo+standard of care..
You don't get Active better than Placebo in every measurement in Phase III by chance.


Dosage is spot on, thats my opinion and I'm sticking to it until I hear any different.

[davidh2133] 15/5/2018 12:15

Nobby is also fretting over on the Galantas Gold BB where he hasn't had the decency to reply.......

[rnsday] 15/5/2018 12:12

Well log in and see nobby been busy again this morning the question I still ask is why are you still here ? Any one would think you still had shares here 🤔You can't let go as I have said before you have become obsessed with it ,if as in your opinion it's 100% dead why does it still concern you so much ? What are you going to post here if it does go to market or get some sort of approval Or deal 😂

[roundup] 15/5/2018 12:07

Nobby! You are still working round the clock to damage a drug which, according to you, is dead in the water. You obviously don't believe your own lie. Why don't you write Lupuzor off and go away, and live a happy life.

[nobbygnome] 15/5/2018 11:37

>> FM

So clearly £100 million is an estimate. However, this is a list of what they have got to do IMHO

1. Reformulate the drug to enable them to deliver a larger amount. I know they had some problems with the 1000 dose so this may be tricky
2. Do further tox studies with the new formulation at a much higher dose
3. Develop a more sensitive assay so that they can actually monitor the exposure of the peptide in patients
4. Do more extensive MOA studies to determine how the drug really works. This will aid choice of the necessary dose
5. Do a large phase II dose ranging study (5 groups of 50 patients?) in a new indication. I suggest CD
6. Assuming the result from 5 is satisfactory do 2 large phase III studies (1000 patients in total?)
7. Of course a lot more drug will be required for the higher dose so they will need to manufacture a large amount of the peptide

That little lot should cost at least £100 million probably considerably more. Of course they could and probably should license after phase II but they failed to do this in Lupus so no guarantee.

Nobby

[che7win] 15/5/2018 10:49

Excellent, this little piggy going to market:



"
A team led by French researcher Sylviane Muller discovered a new drug against lupus whose side effects are virtually nil, the National Center for Scientific Research (CNRS) in France reported. "The drug candidate LupuzorTM has been proven effective in 68.8% of patients who received it," the agency said.

CNRS highlighted that the LupuzorTM is the "first non-immunosuppressive specific treatment" with virtually no side effects. Contrary to the existing medication on the market, the LupuzorTM "does not diminish the immune defenses of patients," said the CNRS. The specialist explained that her medication is not administered in large doses and "probably" will be enough with a monthly injection. The CNRS referred that it is looking to market the LupuzorTM, so "has started discussions with several large pharmaceutical companies."

Little knowledge of the disease
An international survey carried out on a large scale reveals that there is low knowledge about lupus at the level of society in general, which leads to misconceptions and contributes to the stigmatization of the affected people. Lupus is not a contagious disease, nor is it related to cancer or to HIV-AIDS."

[che7win] 15/5/2018 10:48

Not sure Brad, I assume it's ongoing basis.

[brad44] 15/5/2018 10:31

che7win,

do we know how regularly IMM and the NDA's can review any new data?

[che7win] 15/5/2018 10:27

The OLE trial will be especially interesting for the anti-dsDNA group which were previously placebo.

Will make interesting stats.

How many more get full remission? Previously, none on placebo, and 7.6% on active had full remission.

All with zero serious side effects.

On the phase 3 results, will be interesting to see:

1 How many responders did we have under the SRI-4 score.

2. Even more Interesting, how many responders with greater than 4 points improvement?

[cockerspaniel] 15/5/2018 10:15

nobby:You mentioned the OLE trial - I doubt that it will show very anything exciting.

Most of the patienst who entered it will have been responders from the phase III trial (both drug and placebo) and hence the baseline for the OLE will be high.

So, there won't be much scope for further improvement.

[gclark] 15/5/2018 09:36

Can you provide a link to the 1000 monthly dose clinical study report?
thanks

[divinessence] 15/5/2018 09:19

Lupozor WORKS and there is no doubt about it as further analysis of data will prove it. My target takeover price is £1.44 or above. This Nobby character has something else on his mind and in the due course he will be proved wrong.