Immupharma Share Discussion Threads

[wigwammer] 12/12/2017 06:27

"To be considered a responder a patient has to have an improvement in at least 6 of the 24 measures."I imagine improvement between many of the measures are highly correlated. They will know the drop out rate.

[asat91] 11/12/2017 22:49

Yes the placebo effect is 100% psychological.

This can cause some physiological changes as spawny says.

Cannot fix a broken leg with a placebo super

If everyone turns blue I want a mention in the literature

[supernumerary] 11/12/2017 22:11

asat - I don't think we can be talking about the same placebo effect. I'm talking about the one that actually changes the course of a disease (and hence the outcome of a trial), while you're talking about patient delusions.

It's well-established that the placebo effect causes physiological changes - that's its definition - it's not what the patient believes, but also what the doctor perceives. You can only detect it in a blinded trial because it's real.

So going back to where the discussion started, with your 7151, the answer to your question is obviously 'no'. Doctors and patients may guess/assume/believe but they don't know - only after the trial is unblinded do they actually know.

At which point they could, for instance, find out that the drug has zero effect; the placebo effect is very strong; and that the new excipient bound with the drug turns people blue. At that point they discover the difference between reasonable expectation and knowledge ;¬)

[asat91] 11/12/2017 21:52

Fair enough. Thanks for the response and gl 👍

[stanman] 11/12/2017 21:46

1. "Manifestations are legion" - sorry, just that possible symptoms and signs of SLE can be many & varied, as SLE can affect any system in the body.
2. You say 'ASSUMING lupuzor is having a significant effect'. That is exactly the point.
3.We all hope for a positive outcome for phase 111 - it's just hope at the moment. We are though well aware of the high expectations of the triallists.
4.I won't be answering questions I'm afraid. Don't spend much time on here!

All the best.

[asat91] 11/12/2017 21:29

Yes spawny, thanks. Spot on.

Stanman were you a GP or a dermatologist?

What do you mean 'the manifestations can be legion'?

I'm in no way suggesting that it is black and white but are you saying that there is no possibility that the patients, doctors, and IMM have a general idea of who is on the drug and who is not based on apparent symptom resolution (assuming lupuzor is having a significant effect)?

Also what's your take on the probability of a positive outcome for phase III and a low p value for primary endpoints?

You may have made a mistake letting on that you used to work clinically with lupus patients as I will be directing a lot of questions your way now 😂

[spawny100] 11/12/2017 21:24

Perhaps you meant placebo is ineffective at alleviating physical symptoms as opposed to physiological asat? It certainly can change physiological symptoms relating to the psychological ones you mentioned (e.g anxiety symptoms can be heart rate, blood pressure etc). But yes I doubt a placebo could turn someone blue or not of course.

[stanman] 11/12/2017 21:10

asat91 - that's fair comment (7164). Having seen many cases of SLE during my professional life (now well retired!) - the clinical manifestations can be legion (as you know I'm sure).

Even rashes can wax and wane, so that together with the fact that neither patient, nor attending medical professional, know who is taking lupuzor and who is taking placebo - "double-blind" - give no real clue as to what is going on.
Only at the study conclusion, & following appropriate statistical analysis, can any definitive conclusion regarding drug efficacy be drawn.

And again, as I guess you know only too well, a 1-in-20, or less, possibility (P<0.05) that observed results are due to pure chance is often taken as indicating a positive outcome in favour of the drug.
We have to wait to see what "P" is, presumably later in Q1 2018.

[asat91] 11/12/2017 20:48

Super - I am definitely not disputing the existence of a placebo effect!

The placebo effect is only effective for certain types of symptom.

Placebo effect is strong for: Anxiety, Pain, Trouble sleeping, self-report measures and other psychological ailments.

Placebo is inneffective for: reducing tumour size, fixing a broken leg, removing a scar, and other physiological symptoms.

So people might say something along the lines of 'I am not blue anymore' on a self report questionnaire measure, but we would clearly be able to see that they are still blue, as the placebo effect cannot actually change the physiology. So for lupus the arthritis measure will be susceptible to the placebo effect, whereas the rash measure will be less susceptible.

I actually studied the placebo effect at uni and got a 1st class on my third year report so find it funny HK was suggesting I don't understand it!

[blackbear] 11/12/2017 20:32

Anyone thinking they have missed the boat is wrong this could ten bag by the summer.

[supernumerary] 11/12/2017 19:39

HK - 'You do understand that for a disease that turned people blue (regardless of the absurd comparator), they wouldn't run a blind trial, yes?!'

I don't understand, can you explain?

asat - 'the placebo effect albeit strong as it is cannot actually stop someone being blue --> or having bright red rashes in the case of lupus'

I thought that was exactly what the placebo effect did. Are you saying there's no such thing?

[sogoesit] 11/12/2017 18:26

Wearing my rose tinted spectacles this stock in particular continues to look blue to me. Am I colour blind?
;-)

[che7win] 11/12/2017 17:50

asat,
I get you.

[glennrcharles] 11/12/2017 17:48

In a blind trial who can see whether I'm blue or indigo? Come on. !!!!

[asat91] 11/12/2017 17:23

Bob glad to bring a chuckle ;) I was inspired by Eiffel 65

HK I had tongue firmly in cheek, but in all seriousness lupus has some very strong visual symptoms (admittedly not as strong as being blue), so if efficacy is strong I see no reason why this would not be obvious to everyone involved?

PS. the absurd hypothetical was to demonstrate that the placebo effect albeit strong as it is cannot actually stop someone being blue --> or having bright red rashes in the case of lupus

[bobsgonnamakemerich] 11/12/2017 17:12

LOL, I was getting a bit annoyed with all the ramping but asat has tickled me no end :D

[herschel k] 11/12/2017 17:00

You do understand that for a disease that turned people blue (regardless of the absurd comparator), they wouldn't run a blind trial, yes?!

You also do understand the term "placebo effect", right?

Your post suggests otherwise.

[asat91] 11/12/2017 16:54

Yes what's the problem?

[herschel k] 11/12/2017 16:53

asat91 11 Dec '17 - 16:49 - 7151 of 7153

Is this post for real??

[waterloo01] 11/12/2017 16:52

Stanman you are quite correct. I would remind folk that if it did leak it would probably invalidate the trial results.

Edit: or at least might if the last patient hasn't finished the trial.

[greedfear] 11/12/2017 16:52

If they're all blind they don't.

[asat91] 11/12/2017 16:49

Stanman that is not technically true.

Imagine there's a disease that makes people blue.

Immupharma have what they think is a 'cure' for this disease and run a double blind test.

After 6 months, the experiment is still blinded, but 50% of the people are no longer blue.

Do the company and doctors know which patients are in placebo and which are in active?

[stanman] 11/12/2017 16:45

Nice rise today, added more first thing - usually the wrong thing to do but it has ticked up further.
Remember the present study is double-blind & randomized. Pointless then talking about "leaks", insider dealing etc - no-one has any idea about study outcome until all patient end-points are quantified, and participants are allocated to the drug or control group.

[alphapig] 11/12/2017 16:30

Steady stream of buys towards the end on nex.

[waterloo01] 11/12/2017 16:22

Excellent Sp action with any weakness bought into. It does have the 'smell' of a deal somewhere in the background, but might just be speculation.