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I've been invested here for some years now, and they've served me well. I've not had an issue with liquidity. I sold £20k in March (to use up my CGT allowance) and no issues, or issues buying back in my ISA.
As far as Pharma goes this is a relatively safe bet - Generics will only grow, and BXP should complete well on price in this cut throat sector..
They also pay a small cash dividend, which although small, provides a better rate than you would get in the bank (granted that's not saying much)..
Thank you Chris
I won’t be going to the meeting on the 4th but certainly supportive of the additional funding. My feeling is the $25m + BARDA funding should be enough to see these P3 studies through now and really no idea why SUMM are suggesting that this new funding will only extend the cash runway by 4 months. The cost of a clinical trial is driven by 1) the study duration, or more importantly the number of study visits 2) the number/type of procedures undertaken at each visit and 3) the number of patients to be enrolled. Data management costs are also driven by these 3 factors. With regards point 1 - here we’re looking at standard/basic study screening with only a 10 day treatment period, and a handful of study follow up visits (D40, D70 and D100 – maybe some in between?). For point 2 there are no expensive investigations (e.g. MRE, endoscopy, biopsy etc) – just plain and simple clinical assessments, labs, and standard C’diff toxin testing. Point 3 – 1400 pts for a phase III program is not a large # and especially given the straightforward nature of the study design.
I wonder whether SUMM are taking a Big Pharma approach to a small pharma budget? If so they may consider having more team members with small pharma experience in running studies. It’s a very different mind-set, more hands on, more virtual and often means working with small to medium sized CRO’s. You can get from A to B without using a Rolls Royce. Maybe the CFO was pulling his hair out - once he had none left decided to leave?
Chris have you managed to find a way to vote without attending? I’ve not received anything from SUMM (despite emailing), and hold quite a few shares here now.. thank you in advance
Hi alpha - The figures for BBW-11 show same patient #s (in the ITT) and results - almost certainly same study.
Treatment of Grade 2a partial thickness burn wounds (study BBW-11)
The study performed in patients with Grade 2a partial thickness burn wounds (BBW-11) enrolled 66 patients at 10 centres. The ITT group constituted of 57 patients and the PP group of 45 patients.
The primary endpoint was percentage of patients showing earlier healing of the Oleogel?S10 treated wound half compared with the Octenilin® Wound Gel treated half. 85.7% of patients showing a between-treatment difference in time to healing had faster healing with Oleogel-S10 (p<0.0001).
the trial is BBW-11 - I believe..
Appears it was a buy - like you Chris I wondered why someone would sell on the recent good news..
AGM - Trading update 27th Nov
The Group continues to prepare for the upcoming PQ Grass pivotal Phase III trial that can allow for US registration. An end of Phase II meeting with the FDA has now been confirmed for January 2019 and good progress is being made regarding the Phase III trial protocol. Further to previous updates, top line results from the PQ Birch (B301) Phase III trial for Europe are now expected in Q1 2019. Allergy Therapeutics remains blinded to the data package and looks forward to the disclosure of the data.
Hopefully some self-selection in that patients who normally experience the allergy (and thus recruited in the study) live in places where the pollen count is typically high.. – Although I believe birch pollen can travel pretty far..
I think this is worth a buy at 14p – trial may be 50/50 but SP could go back to where it was on good results (or halve on bad!)?.. so short term odds are ok for me..
Revenue should still be there
Looking at the Circassia's trial results this appears to have been caused by a very high/unexpected placebo response rate. Assuming AGY’s PQ Birch works, the most likely reason for failure of their Phase III is for the same reason (high placebo response). Thus I’ve being doing some research into the placebo response rates, in such trials, and found a paper by Nakus et al (2013) – “The placebo effect in allergen-specific immunotherapy trials”. The paper addresses the very wide placebo rate variation amongst these types of studies – and includes 2 birch studies. They discuss various reasons (including route of administration, use of other concomitant therapies) but the one that is most interesting, and very plausible, is actually down the level of allergen the trial subjects are exposed to during the study treatment period. In a nutshell they suggest that if you have a low pollen exposure year then the placebo patients will fare better, and thus the placebo response rate will be high – their exact words “it can be concluded that the amount of allergen exposure is causally related to the magnitude of the placebo effect”
As such I’ve been digging further to see if I can find the Birch pollen levels, during the trial period, in Germany, Austria, Poland, and Sweden this year (the countries the P3 study was conducted in). So far I’ve just found forecasts, but they seem to have predicted the brich levels were going to be high in 2018 (maybe others can find the actual counts now)..
The way the study is conducted it does look like high pollen counts may help reduce the placebo response, and luck may have been on AGY’s side (although not for the poor sufferers!)..
Still going with my research, but at the current SP I’ve dipped my toe in..
PG
Hi Chrisatrdg – for the P3 start dates I’m putting 2 and 2 together - but could be making 5! I know Institutional Review Boards (Ethics committees) are pretty hot on making sure a trial sponsor has all the funds in place to complete the study (2021/22 for results), before they will approve. I’m thinking SUMM will need to demonstrate a cash runway further than end of 2019 before the study can get underway? If they do a deal with another company (and only from experience) the new company will no doubt want to tinker with the details of the P3 protocols – even if discussions have taken place with the FDA/EMA (which don’t necessarily address all the detail). Just a gut feeling of course – and based on tight timelines now.
I assume the SP is stagnating before the Q3 financial results are released next week? There’s a reasonable chance the P3 CDI trials won’t start in Q1 2019 (unless the cash runway significantly increases), so hopefully the market won’t react too badly if this is announced, or maybe the market’s reacted already?
They mention several options to raise funds, but a buyout has to be a high probability. I can’t see why a larger pharma company, doing a due diligence on ridinilazole, wouldn’t come to the conclusion (at this market cap) of just taking over the whole outfit and antibiotic program. Easier in the long run and gets over the tribal politics of SUMM wanting to hold onto their baby. A placing would just be a sticking plaster I think.
Anyway worth a buy at today’s SP (IMHO) and the sells at 20.7 are actually buys.
Good RNS - and they've secured a higher royalty than most in this industry.
I also noticed in the interim the statement..
Phase III AEGIS-CKD achieved statistically significant response against primary endpoint..
Is this new good news? The SP took a hit when this study missed statistical significance on the primary - I may have missed a re-analysis and RNS, but this also sounds positive.
Hi GoldenDust � I�m not sure how often you frequent this site but as an IDA sufferer have you been able to get access to Feraccru? I see you are on IV but as you say a new oral would save time/travel and inconvenience thus wondered how accessible it actually was in the UK, and whether the poor sales in the UK (although much better elsewhere) were down to accessibility of drug? Thank you in advance and appreciate if you don�t want to answer anything about your personal experience. I decided to invest here when STX announced their EU license expansion, to iron deficiency +/- anaemia. No mean achievement to get this (without a specific study), and gave me confidence in their regulatory team. I think they have a good chance with the NDA for CKD - given the FDA looks (from what we�ve heard) like they�re being pragmatic about the AEGIS-CKD Phase III study results � probably given the proven MoA. � I think the H2H study against IV ferric carboxy maltose will be interesting � non-inferiority and stands a reasonable chance of success. Ferinject is exceeding CHF500 million in sales and growing, so not a bad H2H. Issue may be that with IV we know there is a100% bioavailability in 100% of patients so fingers crossed Feraccru can compete..
NKOTBUK � good post (and thank you for the mention) - you asked what was the drop-out rate in each arm? I calculated this to be 23.8% on active and 24.8% on placebo. Calculations below for reference� From the numbers presented in the RNS, and your post, it appears from the %�s that the groups were evenly split with 101 in each arm (total N=202). Looking at the ITT (52.5% vs 44.6%) the actual number of patient responders on active therefore was 53 (giving 52.5%) and 45 responders on placebo (giving 44.6%). As you say in the completers analysis (PP pop in your post): n=153, active vs placebo = 68.8% vs 59.2%. As we know the numerators from the ITT (53 and 45), these will be used in the completer�s analysis, so we can calculate the denominators from the %�s, which provides us with the drop-out rate. Note: this was a completers analysis so N=153 should reflect the number of actual completers, rather than a true PP pop (which may have less #s when they exclude patients who didn�t completely fulfil the eligibility criteria, or who had significant protocol deviations etc.) Looking at the completers analysis - active therefore was 53/x=68.8% - so �x� would be 77 completers in the active group. For placebo it would be 45/y=59.2% � y� must =76 completers on placebo. From the above we have 24 (23.8%) dropouts on active (101-77) and 25 (24.8%) dropouts on placebo (101- 76) i.e. a pretty much even split between the groups.. I put a post on the iii BB on the 9th of Feb 2018 - with assumptions of a 20% drop-out rate. This is about par for a one year trial of this nature I believe (in my experience at least)..