WildBillHiccup
17 Apr 2018
Re: Thank you Many thanks Pharma Giles. Have been reading your comments about P3 and found them very helpful. So much so that my investment in IMM was sold a while ago (had 40K at one stage) It was all too good to be true, sadly. TM's comments rang a bell too - of AZM not that I can remember that debacle too clearly, but it rand the wrong tune to me. Your comments rang true throughout, and many thanks.
dallo
17 Apr 2018
Holding RNS With close to 50m shares traded today compared to 140m in issuea spate of holdings RNSs ( or maybe just one) should start to appearin the next few daysSomeone( or a number of parties) has picked up a major stake in Immupharma on the cheap particularly given that the trial results may not be that bad after all imho
Dhanna
17 Apr 2018
Re: Analysis PGI am sure IMM read this board.Surely you should contact with your expertise and help reverse the decimation.Thanks.Regards D
Pharma Giles
17 Apr 2018
Analysis Reducing the placebo response rate is an art in any clinical trial.... I should point out it's my job to know much more about drug development than any small company..If IMM are reading this my suggestion would be to present the Week 12response rates - if they also show a superior effect to placebo then undertake a sustained response/remission analysis. The eligibility criteria of SLEDA>6 for inclusion will only help drive out the delta (difference between active and placebo) for the induction phase of the study at week 12 (see my previous post on induction vs maintenance) but will have little influence on the maintenance phase.. When you go out to Week 52, with your primary time-point, the baseline disease activity has less influence on driving out the delta, as a subjects disease activity 1 year ago is too far in the past, and will naturally change as part of the normal fluctuation of the disease over the longer term..The analysis I would recommend (assuming week 12 was good) is to look at the proportion of patients in response at both Week 12 AND Week 52 (i.e. combined response rate for a single responder analysis). This will drive down the placebo response more so than the active (if superiority was also seen at week 12).. If positive you will still be able to use the data to support an NDA for a long-term label claim, but naturally will need another study with this as your endpoint (in patients with anti-dsDNA autoantibodies).. it may allow less patients to be needed for the next study though..Good luck and would like to see some good out of this... all is not lost here...
snark_hunter
17 Apr 2018
Results Todays results which failed to show a statistically significant improvement are very disappointing and the market has reacted but I think current market value is an over-reaction. The facts are that the drug is safe and improves the life of Lupuzor sufferers.In the fullness of time will recover due to a better realisation of the following:- Lupuzor did achieve 7.9% uplift over standard treatments but not proven beyond statistical doubt. - The effectiveness among the 153 patients that got to the end of the course of treatment was 68.8%, which was 9.6% above standard treatment but no statistical significance test yet available.- In a specific sub group there is a 14% uplift, very close to the statistical significance test, and of these 8% went into remission whereas non in control group did.- No patients had any side effects whereas standard treatment includes steroids, anti-malarials, and other drugs which all have side effects, some very severe, over the longer term- The detailed results have yet to be produced and discussed with the FDA- The open label extension completes in October which may add further support for Lupuzor’s efficacy without further trials and a deal- Lupuzor appears to have general effects against auto-immune and even chronic inflammatory indications and pre-clinical evidence supports the molecule's use in: Neuropsychiatric lupus (NPSLE); Gougerot-Sjögren Syndrome (GSS); Guillain-Barré Syndrome; Chronic Inflammatory Demyelinating Polyneuropathy; Arthritis; Crohn's Disease and Asthma. All of these are commercially attractive and large marketsKey are the discussions with FDA which is moving to a more patient centred approach to drug approvals; the drug is safe and does improve the life of Lupuzor sufferers.Fortunately the company has £10m in the bank, and has several other oncology and diabetes drugs in the pipeline, and 2 drugs platforms, which may be of interest to pharmaceutical companies in any deal which I suspect will be forthcoming but not at the stellar valuations we were hoping for.Statements from company:“Whilst we are disappointed at the high response in the placebo plus standard of care group that resulted in statistical significance not being reached between the two treatment groups, we believe Lupuzor has the potential to bring a much needed safe treatment to the millions of Lupus sufferers around the world.”top line results “provide evidence for the continued investigation into the development and commercialisation of Lupuzor”. It thinks the drug has the potential to offer patients and physicians a much needed effective and safe treatment for lupus.“ImmuPharma is in ongoing discussions with a number of larger pharmaceutical companies,” it added.“The results of this study will now be shared with those potential commercial partners. There can be no certainty as to the outcome or timing of these discussions.”
Cantseethewoodsforthetrees
17 Apr 2018
Re: Wakey, wakey! Pharma Giles,Many thanks. I have appreciated your reasoned comments.Amazing how well 'Placebo' seems to perform in all these trials....
Pharma Giles
17 Apr 2018
Re: Wakey, wakey! Unfortunately the study was underpowered... Just to put in context if the 7.9% was a true treatment difference, between active and placebo, you would have needed 1678 patients in the study (839 per group) to see the difference statistically, based on a 90% power... 200 was always optimistic (others may use a different term!)...It's now all about digging into the data and finding the subgroups that responded best. The study was really only a Phase II and will now be treated as such. It will be up to IMM to convince any would-be partner that the positive subgroups are not cherry picked, and are truly likely to respond better in any future study... It will be tough but do-able, if IMM haven't lost too much credibility..My hope is this hasn't put investors off investing in pharma/biotech (we need your money for research). This study was always, on probability, likely to fail to reach statistical significance (see my previous posts) and run by a team that didn't appear to have sufficient experience in drug development... I also think some of the analysts/brokers should be hanging their heads in shame with their ridiculous/unfounded predictions..I'm truly sorry if genuine investors have lost a lot of money here. I hoped my posts would balance out the misleading comments provided by IMM, and the rampers..
Johnoooo
17 Apr 2018
Re: Wakey, wakey! Who is correct the directors with their upbeat comments or the market with share price reaction?Actually the answer is obvious for shareholders.....market every time. Begs the question why the directors are so positive and clinging on for every glimmer of hope!
Nice to Michu
17 Apr 2018
Re: Wakey, wakey! awful news and truly enormous fall this morning.. commiserations to all including myself.. fortunately I'd sold a lot of my position down over previous months but the few thousand shares I have left are decimated... sit, watch and hope that something can be resurrected from the ashes is all I can now do I guess....incredible fall this morning mind.. but it's a one trick pony and I guess that's why..I have thought about topping up a little in low 20's p as a punt but have not so far..
Cantseethewoodsforthetrees
17 Apr 2018
Wakey, wakey! Topline results out.Pharma Giles-comment please?
Pharma Giles
16 Apr 2018
Results Must confess I thought the results would be out this morning. As way of insight the company are only expecting/reporting top-line results at this moment in time. This typically includes the results for the primary endpoint and key secondary’s. As the data is limited to the key endpoints it’s straightforward to interpret. Deeper analysis comes later when the full data set is available, and you can dig deeper into the results/subgroups (so in a couple of months). The results are usually provided in SAS table format, as a PDF – and very easy to read. As the ITT has 100 patients on active, and 100 patients on placebo it makes it even easier to see response rates (%s = the numerator in each group ) – then you look at the p-value to see if it reached statistical significance (p = <0.05). As this has been deemed a Phase III, by the company, it makes the outcome black or white – either the study reached statistical significance for its primary endpoint, at week 52, in the Intention to Treat (ITT) population, or it didn’t i.e. it’s pass or fail based on this.. Phase II has a little more flexibility about its overall interpretation (as it’s exploratory, rather than pivotal). As a note most pharma companies I’ve worked with would have run the IMM Phase III study as a Phase II, it would be deemed too risky to run as a Phase III (see my previous posts). I understand Cephalon pushed IMM back on calling its study a Phase III – and subsequently ran as a Phase II.In a nutshell the results should be instantly interpretable – as for a Phase III they’re based on the primary endpoint/timepoint (one key table).. – hopefully no delays..
hitch19
05 Apr 2018
Data lock PhGA less than 0.30 ? Anyone.....?
BuySel
04 Apr 2018
Re: Has the market factored in the likel... From the "UPS" threadIMM 158p -15ptoday's drop following yesterday's large rise and losing half, was a 38.2% retrecementchart[link]
Pharma Giles
02 Apr 2018
Re: Has the market factored in the likel... Good posts WW - as you say all about the results and so you think the market's built a second study into the SP? My thoughts were it hadn't but was glad to get another balanced opinion. Re: predicting a study outcome based on blinded data - yes it's pretty near impossible to say which way efficacy will go when the data is still blinded. I learnt this early on in my career. I wasn't sure if TM was suggesting otherwise - apologies to him if he wasn't..
wigwammer
02 Apr 2018
Re: Has the market factored in the likel... ...just to add, i take your point about overconfidence prior to unblinding. But if a drug were to demonstrate a highly positive result, in the way imm hope and expect, then one indication is likely to be a positive trial response of the nature they are describing re extension etc. It is difficult to envisage a situation where a very high number on the active respond, in addition to a typical response to those on placebo, and there be no visible indication of this prior to unblinding. They need to see safety, a positive trial response, and a relatively low placebo response to get an outstanding result - so far, they have two out of three.. fingers crossed, ww
