Pharma Giles
28 Feb 2018
Re: Does anyone read this BB? Hi DD – I’d imagine IMM have the timeline for DBL pre-agreed with their Vendor (typically c4-6 weeks after last subject out). Normally DBL is a milestone that the clinical team work to (with the PIs and sign off as well), but maybe I can understand TCs reluctance to share the date…. Agree with you about the speed to which the primary can be pulled following DBL.However, I decided yesterday to sell my long held stock, (get the impression the market won’t be so accepting of another Phase III as me) so my interest now is curiosity in results. Might buy back in after?
decision decision
27 Feb 2018
Re: Does anyone read this BB? Hi, and yes but not often. Was alerted to it on twitter group. Good post by the way and agree once locked it could take seconds to the top line results, but as I suspect you have experience of, it's only once all the data is in that they can check any potential conflicts/issues with trial centres. Depending on the nature and number of these, it would delay the lock. Having said that, can't be long now.
Pharma Giles
27 Feb 2018
Does anyone read this BB? I'm not on any of the other forums but had a look at LSE and ADVFN and some very good updates on last nights event.... Have to ignore the clinical interpretation by a lot of the rampers on ADVFN (they don't look like they've had any pharma experience) but some good snippets in-between the ramping posts..
Pharma Giles
26 Feb 2018
Tonight's Investor meeting Is anyone going to the investor meeting tonight? One question, if possible, would be the timeline for database lock (DBL) - this is the point at which you can unblind the data? If anyone can ask, that would be great, as we’re now over 5 weeks since last patient out, and 9 weeks since the last week 52 visit. The study would have used electronic data capture (eCRFs) and the data cleaned as the trial progressed, so database lock should have probably happened, especially as Simbec-Orion have an invested interest, and would have put their A team on the data management. Although there will be literally 000s of pages for the full tables and listings, as this is Phase III there is one table that counts more than any other and that’s the responder analysis for the primary endpoint at week 52 in the Full Analysis Set (ITT pop). To generate this table, following DBL, is very quick (could do same or next day if you really wanted to). It will take several weeks to generate the full tables and listing, analyse the subgroups, and write a report, but IMM should know now whether the trial has been successful.. Phase III’s a bit more black and white than Phase II in as far as a definition of success goes at least.I was hoping an RNS would be released ahead of todays’ meeting? I couldn’t work out the purpose otherwise – we know what Venture Life aims to talk about, but not IMM? The other indications are interesting, as is the size of the market, but in a nutshell we really need the Phase III topline result first I think… Presenting on the night will be; Mr Tim McCarthy Chairman of Immupharma plc IMM.L (www.immupharma.co.uk). TPI acted as Placing agent in the recent £10m fundraise. Mr Jerry Randall – CEO of Venture Life Group plc VLG.L (www.venture-life.co.uk) TPI is joint broker to Venture Life and Jerry will be providing an update on recent developments and future plans for the company.
Nice to Michu
15 Feb 2018
Surprised by extent of recent weakness Raise was at 144p too - and, as Rick points out, that was indeed not them out looking with cap in hand but an approach from ii(s) wanting to get involved - and so s/p weakness from 180p ish can be categorised as significant now...and for bulls here a potentially good buying opportunity has arisen, perhaps. As a bull here I have started to buy back small amounts recently - had sold down 90% of my original holding from 80p ish up to 170p ish - and will likely continue to do so, especially if goes sub 100p..Not long to wait either as there will be and announcement on phase 3 trail results sometime in next 6 weeks and that will have a huge impact one way or other here. Granted, a nagging doubt on leak about some lack of 'success' does creep when the s/p has come off like it has recently but my guess remains that it will have been a successful trial and will get some sort of FDA ok - maybe not fast track - to progress towards market off the back. Also I note also they said in the raise update RNS that discussions are ongoing with partners towards getting Lupuzor to market: ''The proceeds of the Placing allow the Company to make investment into potential indications emanating from the Company's P140 platform, in addition to lupus. The Placing further strengthens the balance sheet and enhances ImmuPharma's position in ongoing and future negotiations with potential partners for Lupuzor™.We look forward to providing our shareholders with further updates regarding the Lupuzor™ Phase III trial with key data still on track to be announced before the end of Q1 2018." ''I think that a top partner coming on board in some shape or form here could be transforamtion to s/p
Pharma Giles
11 Feb 2018
Re: Why raise funds now? Hi Rick43Unfortunately drop outs are part and parcel of any long term trial I’m afraid. Even open-label studies, with licensed products, and good safety/efficacy profiles, we still see 20% dropouts in a year. There are many reasons for discontinuation, worsening of condition (even with the best drugs), AE’s, lost to follow up, or even patients withdrawing consent because they wish to receive a new licensed product that wasn’t available when they initially consented to a placebo controlled blinded study. To power a study you normally account for dropouts, but of course this could be slightly higher or lower than your assumptions. As a note I see that the estimated enrolment for the new extension study is 100 patients (as per clinicaltrials.gov). I would assume however more than 50% of patients made it through week 52 though.Hi WildBill I’m not the same PJ, sorry. My background is very much in clinical/drug development so there are better people when it comes to the financials, and charting. It's why I sometimes look at BBs as well..
rick43
10 Feb 2018
Re: Why raise funds now? Pharma GilesWhat other SLE trials had so little in the way of side effects as Lupuzor? Lupuzor has been described as benign in terms of side effects. Why would anything like as many as 20% of the active arm Lupuzor patients drop out? Their lupus symptoms will be decreasing as the trial progresses and they will not have been put off continuing in the trial as a result of side effects. IMM did not raise £10mn - it was offered to them.
WildBillHiccup
10 Feb 2018
Re: Why raise funds now? Hello PJ (assume that you are the same as pharmajiles on the FUM bb but if not ,apologies). I hold a few IMM as well as (rather a lot more) FUM and given your proven ability on charting the FUM share price I wondered whether you have charted IMM to such a degree?? I just also wondered where the share price might end up if you are correct and they need another study?
Pharma Giles
09 Feb 2018
Re: Why raise funds now? All is dependent now on whether the trial is successful. As this is a Phase III study, success means reaching statistical significance (p value <0.05) on the primary endpoint (at week 52). Although the FDA may look at the secondary’s, unless the trial hits on the primary, the secondary’s will really only be of academic interest (and another study will almost certainly be required). So the key question is what’s the probability of the study hitting its primary?To evaluate this if we first look at the likely placebo response rate. (Note: this isn’t a true placebo group as it’s an “add-on” to standard of care, thus increases the placebo groups response rate). If we look at the Benlysta study with a similar primary endpoint, study design, at the same primary time-point, we saw placebo rates of around 48% (as per GSK website). If we look the Lupuzor phase II we saw at week 24 the placebo rates were 53% (placebo patients off treatment). This gives a starting point for assumed placebo rates at the longer term (primary) time-point of week 52. It’s harder to gauge the likely Lupuzor response rates at week 52 as I could only find one other trial at the longer term time-point (Study C33457/2047), which failed to demonstrate a difference between placebo and active. So working backwards, if we assume a best case scenario of 40% placebo response rate and we have 200 patients in the trial, we would need a >60% response rate in the Lupuzor group to achieve statistical significance (based on an 80% power). Power determines the ability to detect a treatment difference when one exists. Phase IIIs are often powered to 90%, but you would need at least 258 patients to achieve a 90% power, based on a 20% difference in treatment arms (hence the Benlysta Phase III studies recruited over 800 patients to each study, and achieved statistical significance with a smaller difference). Now, we have to consider “drop-outs”. In a trial of this nature the normal drop-out rate, over 1 year, would be around 20% (and this appears to be the case with other SLE trials). The trail will most likely consider drop outs (missing data) as non-responders (i.e. assuming no LOCF will be used). What this means is although 100 patients will start on Lupuzor, around 80 will complete to week 52. The denominator however will be based on the starting number of 100 (ITT population – those who received at least one dose of study drug ). This means to get a >60% response rate on active you would need >60 out of the c80 patient completers (i.e. >75% response rate in those evaluated at week 52). Although not impossible, based on probability it will require another study to satisfy the FDA.. IMHOA long winded answer as to why raise £10 million now… but hope it helps..
Pharma Giles
09 Feb 2018
Re: Why raise funds now? All is dependent now on whether the trial is successful. As this is a Phase III study, success means reaching statistical significance (p value <0.05) on the primary endpoint (at week 52). Although the FDA may look at the secondary’s, unless the trial hits on the primary, the secondary’s will really only be of academic interest (and another study will almost certainly be required). So the key question is what’s the probability of the study hitting its primary?To evaluate this if we first look at the likely placebo response rate. (Note: this isn’t a true placebo group as it’s an “add-on” to standard of care, thus increases the placebo groups response rate). If we look at the Benlysta study with a similar primary endpoint, study design, at the same primary time-point, we saw placebo rates of around 48% (as per GSK website). If we look the Lupuzor phase II we saw at week 24 the placebo rates were 53% (placebo patients off treatment). This gives a starting point for assumed placebo rates at the longer term (primary) time-point of week 52. It’s harder to gauge the likely Lupuzor response rates at week 52 as I could only find one other trial at the longer term time-point (Study C33457/2047), which failed to demonstrate a difference between placebo and active. So working backwards, if we assume a best case scenario of 40% placebo response rate and we have 200 patients in the trial, we would need a >60% response rate in the Lupuzor group to achieve statistical significance (based on an 80% power). Power determines the ability to detect a treatment difference when one exists. Phase IIIs are often powered to 90%, but you would need at least 258 patients to achieve a 90% power, based on a 20% difference in treatment arms (hence the Benlysta Phase III studies recruited over 800 patients to each study, and achieved statistical significance with a smaller difference). Now, we have to consider “drop-outs”. In a trial of this nature the normal drop-out rate, over 1 year, would be around 20% (and this appears to be the case with other SLE trials). The trail will most likely consider drop outs (missing data) as non-responders (i.e. assuming no LOCF will be used). What this means is although 100 patients will start on Lupuzor, around 80 will complete to week 52. The denominator however will be based on the starting number of 100 (ITT population – those who received at least one dose of study drug ). This means to get a >60% response rate on active you would need >60 out of the c80 patient completers (i.e. >75% response rate in those evaluated at week 52). Although not impossible, based on probability it will require another study to satisfy the FDA.. IMHOA long winded answer as to why raise £10 million now… but hope it helps..
Pharma Giles
09 Feb 2018
Re: Why raise funds now? All is dependent now on whether the trial is successful. As this is a Phase III study, success means reaching statistical significance (p value <0.05) on the primary endpoint (at week 52). Although the FDA may look at the secondary’s, unless the trial hits on the primary, the secondary’s will really only be of academic interest (and another study will almost certainly be required). So the key question is what’s the probability of the study hitting its primary?To evaluate this if we first look at the likely placebo response rate. (Note: this isn’t a true placebo group as it’s an “add-on” to standard of care, thus increases the placebo groups response rate). If we look at the Benlysta study with a similar primary endpoint, study design, at the same primary time-point, we saw placebo rates of around 48% (as per GSK website). If we look the Lupuzor phase II we saw at week 24 the placebo rates were 53% (placebo patients off treatment). This gives a starting point for assumed placebo rates at the longer term (primary) time-point of week 52. It’s harder to gauge the likely Lupuzor response rates at week 52 as I could only find one other trial at the longer term time-point (Study C33457/2047), which failed to demonstrate a difference between placebo and active. So working backwards, if we assume a best case scenario of 40% placebo response rate and we have 200 patients in the trial, we would need a >60% response rate in the Lupuzor group to achieve statistical significance (based on an 80% power). Power determines the ability to detect a treatment difference when one exists. Phase IIIs are often powered to 90%, but you would need at least 258 patients to achieve a 90% power, based on a 20% difference in treatment arms (hence the Benlysta Phase III studies recruited over 800 patients to each study, and achieved statistical significance with a smaller difference). Now, we have to consider “drop-outs”. In a trial of this nature the normal drop-out rate, over 1 year, would be around 20% (and this appears to be the case with other SLE trials). The trail will most likely consider drop outs (missing data) as non-responders (i.e. assuming no LOCF will be used). What this means is although 100 patients will start on Lupuzor, around 80 will complete to week 52. The denominator however will be based on the starting number of 100 (ITT population – those who received at least one dose of study drug ). This means to get a >60% response rate on active you would need >60 out of the c80 patient completers (i.e. >75% response rate in those evaluated at week 52). Although not impossible, based on probability it will require another study to satisfy the FDA.. IMHOA long winded answer as to why raise £10 million now… but hope it helps..
Aberdeen_investor
03 Feb 2018
Why raise funds now? The recent interview was very positive, the impression that was given was the results would be excellent and that it's basically a "done deal"...I hope the results are as good as everyone is expecting them to be, but just an honest question.. please don't shoot me down for asking this...If the management are so confident, why dilute existing share holders now to raise funds? It's not like there was a massive waiting time till the results of the clinical trials are released so why raise funds now? If I were management and confident of good results, I would have waited till end of 1Q and if funds were needed, I would have raised them then, in a much more powerful position....
II Editor
02 Feb 2018
NEW ARTICLE: Six AIM pharma shares on verge of breakthrough "Last week, I wrote about companies that have disappointed in recent times, but have potential to bounce back this year. This week covers health and pharma companies that may have been taking years to develop a product or technology and they could ..."[link]
Volsung
18 Jan 2018
Upbeat Interview with Tim McCarthy CEO [link]
tikky
18 Jan 2018
up oday thankxwhen will be Q1 resultsit is yo yo today 160-170imho
