Share Name Share Symbol Market Type Share ISIN Share Description
Evgen Pharma Plc LSE:EVG London Ordinary Share GB00BSVYN304 ORD 0.25P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.0% 7.45 7.30 7.60 7.45 7.45 7.45 0.00 08:00:00
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 0.0 -3.1 -2.7 - 10

Evgen Pharma Share Discussion Threads

Showing 1626 to 1650 of 1850 messages
Chat Pages: 74  73  72  71  70  69  68  67  66  65  64  63  Older
DateSubjectAuthorDiscuss
28/9/2019
10:29
FAO Diamondstar - that’s what I said o) I understand why primary and secondary are released together - and why it could compromise the trial in commercial eyes not to do so.
pennyfalls
28/9/2019
05:14
Thanks Timbo , from 5th March to the 18th March 2019, it is factually possible, they could have collected 99.26% of all the data for the whole SAH trial. Primary + Secondary. Combined.
90005nelson
27/9/2019
21:56
"I don't see how the primary endpoint data could effect the secondary endpoint data" I can. For example, if the investigators have already seen the PK data, they will know exactly which patients will have been treated with active and which patients will have been treated with placebo. If the collection of the cognitive measures is still ongoing, then the investigators will know which patients were on which treatment (i.e. they will be unblinded) during data collection and bias will inevitably creep in, especially given the subjective nature of some of the measurements
timbo003
27/9/2019
17:43
Yeah I think we're getting somewhere near the mark. I believe Evgen Pharma's in informal talks with potential deal or deals. That's why, they decided to combine the release of the primary and secondary endpoint data. I don't believe one would compromise the other as previously stated by people, but it could very well compromise a deal or deals.
90005nelson
27/9/2019
17:12
>> timbo Completely agree. You would never sign a deal with more data imminent. If that data was negative, the career of whoever championed that deal would be severely compromised.
nobbygnome
27/9/2019
17:07
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment.Primary Endpoints: improved blood flow (ultrasound) associated with the DCI, levels of drug in plasma and cerebral spinal fluid & safety Secondary endpoints: cognitive measures at 3 and 6 monthsStanford–Binet Intelligence Scales: By measuring the memory, reasoning, knowledge, and processing power of the user, this test is able to determine "an individual's overall intelligence, cognitive ability, and detect any cognitive impairment or learning disabilities."I don't see how the primary endpoint data could effect the secondary endpoint data. I don't know if Diederik would agree either.
90005nelson
27/9/2019
14:52
Pennyfalls... Releasing Primary and Secondary Endpoint data simultaneously makes perfect sense, as Timbo has discussed... because the knowledge of the Primary Endpoint could influence the results of the Secondary Endpoints. Paradoxically, the Secondary Endpoint i.e. neurological recovery will be more important than the Primary (vascular dilation). The reason for Evgen selecting the Primary Endpoint could be the anticipated Pharmacodynamic effect - the study is adequately powered to detect a certain amount of vasodilation by Study Drug. However, the study may not be adequately powered for Secondary Endpoints. Hence, there are few possibilities here in terms of overall results - ideally, the Primary as well as Secondary will be statistically and clinically significant. But an alternative could be the Primary would meet statistical significance but Secondary - show a trend for improvement but not meet statistical significance. Both of these scenarios - would be viewed as positive results, and would support progression to Phase 3. However, there are other results which could be viewed as negative e.g. if Primary Endpoint is positive, but there is no trend for improvement in neurological or cognitive function. Anyway, interesting times ahead for Evgen. I am not a shareholder at the moment, but interested in the MOA of the drug.
diamondstar1
27/9/2019
12:31
Therefore the RNS 18/03/2019 the advice given below must have been compelling.Following advice from clinicians and statisticians, and in the light of commercial considerations, the Company has decided to announce the primary endpoints (safety, tolerability and measures of blood flow in the brain) and secondary endpoints (relating to cognitive function) at the same time,
90005nelson
27/9/2019
12:25
I can prove beyond any doubt, that Evgen Pharma had absolutely no intention of holding back primary endpoint data for the SAH trial in February 2019.
90005nelson
27/9/2019
12:00
Yes Nelson...it's been pushed back to Q4...first they said "early Q4" but now just Q4.. Probably usual Pharma delays.
pennyfalls
27/9/2019
11:45
Just to be Chrystal clear from Evgen Pharma's own presentation. Read-out of primary and secondary endpoints expected in Q2 2019 and late summer 2019 respectively
90005nelson
27/9/2019
11:03
Hi Nelson... just musing here, but it sounds like 'transference' - ie you're trying to wrongly conflate two separate study endpoints? Maybe i'm wrong? So, are you saying because STEM primaries were good that this transfers to SAH? I could be wrong, but I think that one such endpoint that does transfer appears to be safety of the drug, but otherwise they appear radically different things. I've also gleaned from reading this board and LSE that some people believe that releasing both endpoints together for "commercial reasons" is de facto proof enough of success, but Timbo's assessment seems to be the right one - ie, they need to know without mitigation or fear of compromise that the fist endpoint data has not influenced in any way the Secondary endpoint result. And that the final outcome is 'clean'. Thus , if successful, this is a 100% success without fear of prejudice - but does NOT guide towards a successful result at this stage (in secondary endpoints) (I allo understand the caveats that , despite being blinded, some Study Staff may have been able to "guess" if the drug is working, especially if remarkable / obvious effects)
pennyfalls
27/9/2019
10:24
Thanks for your reply, so in that case what do you make of the RNS 25/03/2019 SFX-01 meets primary endpoints in Phase II STEM trial
90005nelson
27/9/2019
10:09
>>>>Nelson I doubt if the timings were ever stipulated in the protocol for reporting the primary and secondary outcomes, in my experience the default would be that all results are reported simultaneously. Certainly there was no corresponding notification of any change relating to this at Clintrials.gov https://clinicaltrials.gov/ct2/history/NCT02614742?V_8=View#StudyPageTop I suspect the directors had at one stage contemplated reporting the results from the primary (blood flow, PK and safety) variables before the other outcomes as they thought it might accelerate negotiations with potential partners and thus mean one less (or a smaller) dilutive placing. However, they then may have concluded (possibly following feedback from potential partners) that by analysing the primary data first, it would detract from the value of the secondary (more clinically relevant) data, so on balance they decided to maximize the potential value and attractiveness of the project at the expense of timings, this was definitely the correct decision IMO. In my experience, project teams within Big Pharma companies tend to be full of risk adverse, career conscious individuals. If they are tasked with evaluating a project from an outside source and are then told there will be additional data coming along in a couple of months, then in 100% of cases they will defer any decision on whether to pursue the project until they have seen the additional data (Nobby might wish to comment on this point too).Therefore there would be no point handing over half the data set, if there were more data to follow within a month or two.
timbo003
27/9/2019
09:56
I'm invested, but I'm more intrigued than anything. The job role of a statistician and the job role of a clinician, within and towards the end of a trial, giving commercially revelent advice to the BOD. The BOD then decides to change it's agenda, just to maximize commercial value of the dataset. I can only assume that the advice given must have been compelling. Compelling enough for the BOD to act upon this advice given and compelling enough for the BOD to reveal the source from which they made their decision. My own personal opinion, is that this information wasn't directed at shareholders per se but towards potential co-investor partners.
90005nelson
27/9/2019
08:43
So are you bearish or bullish on EVG, Nelson?
lovewinshatelosses
27/9/2019
07:00
Could you give an example of where the goalpost, in a trial like this, has been moved some 35 months into the above trial. The treatment for participants has remained constant throughout, The study is a randomised, double-blind, parallel-group design comparing SFX-01 (300 mg) taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily for up to 28 days versus placebo in 90 patients who have had SAH and present within 48 hours of ictus. Also what could be the revelent commercial only advice, clinicians could give differently at that time in the trial , opposed to at the start or before the trial started? The only thing that has changed is the decision to withhold primary endpoint data for commercial purposes after that threshold has been crossed with a significant (27months worth) of secondary endpoint data.
90005nelson
26/9/2019
17:16
Thanks Timbo - excellent post
pennyfalls
26/9/2019
12:14
They've recently removed pre-emption rights, which would help facilitate a merger.
90005nelson
26/9/2019
12:07
My thanks too timbo; I have also read a few of your posts over time, and value your opinions highly. I am torn over whether to add or simply to hold here; this relentless selling on no bad news has influenced my original plan to have a little top up if it went back to circa 15p (and I may well kick myself for not being more brave here). Right, I will leave you all in peace for now, as I am conscious that I am not actually bringing anything of interest or particular note to the table here! Have a good afternoon gents and ladies.
lovewinshatelosses
26/9/2019
11:54
Definitely not a seller Nobby, would like to buy a few more, but I probably have enough already.
timbo003
26/9/2019
11:33
Thanks timbo! So are you a buyer, a holder or a seller at this juncture?
nobbygnome
26/9/2019
11:29
A few thoughts following some of the recent comments on the SAH study First of all, it is worth bearing in mind the market’s perceived potential value (and risk adjusted value) of the company’s clinical assets: Finncap Initiation note (April 2019) Metastatic breast cancer value of (£30m) 30p per share that would rise to c.£60m (60p) on a successful Phase IIb study. This excludes any upfront licensing payment that would be expected on successful completion of the proposed Phase IIb study. This could be of the order of order of $50m or c.35-40p per share. The de-risked NPV is c.£300m (excluding upfronts and/or milestones). Subarachnoid haemorrhage value of £14m (15p per share). A positive readout of its Phase IIb study in Q3 2019 would value the potential royalty stream at c.£50m, which together with the value of a potential upfront payment (c.£30m), should the company license the asset, implies an asset value of c.£80m. Our target price attributes no value to any investigator-initiated studies in which Evgen would supply SFX-01 for Phase II trials in fatty liver disease (NASH), autism spectrum disorder and intra-cerebral haemorrhage (ICH) whilst retaining all commercial rights. Our target price valuation would rise to at least c.£80m (80p) on a successful Phase IIb trial result in SAH. The downside risk, should the trial fail, is around 7p in our opinion. The current share price is more than supported by the breast cancer indication alone (c.30p). Finncap update (May 2019) The Phase IIb trial of SFX-01 in subarachnoid haemorrhage (SAH) is expected to readout in Q3 2019, following advice from clinicians and statisticians to leave the study blinded until completion of both primary and secondary cognitive endpoints at six months post treatment. A successful outcome would see our risk-adjusted value for this indication rise from c.£15m to c.£80m. Our forecasts are unchanged apart from cash and LPS, which is reduced to take account of the 25% enlargement of share capital. Our target price is reduced to 35p to reflect this dilution. Our risk-adjusted target valuation of c.£45m would rise to c.£110m upon a successful Phase IIb readout for SAH, implying an increase in the target price to c.85p. On March 18th the company stated: Following advice from clinicians and statisticians, and in the light of commercial considerations, the Company has decided to announce the primary endpoints (safety, tolerability and measures of blood flow in the brain) and secondary endpoints (relating to cognitive function) at the same time, rather than announcing them separately as previously indicated. I would have been very surprised if they hadn’t taken that decision given the study design. The primary outcome is cerebral blood flow and one of the the secondary outcomes is cognitive function ( 7 , 28, 90 and 180 days post stroke). In reality, everyone (i.e. Clinicians, Investors and potential partners) will be far more focused on the secondary than the primary, so why compromise the blinding (and the statistical significance) for the outcome which is of most interest by prematurely analysing and reporting result from the primary measure (which will be of much less interest)? This is particularly relevant in the SAH study as the cognitive function will be assessed using the modified Rankin scale (0-6 ordinal scale) https://clinicaltrials.gov/ct2/show/NCT02614742?term=evgen&rank=2 This will inevitably involve some subjectivity when assigning a score (with the obvious exception of scoring a maximum 6), therefore it extremely important to maintain the integrity of the blinding https://en.wikipedia.org/wiki/Modified_Rankin_Scale http://www.modifiedrankin.com/input? Given the lack lustre share price action in the last few weeks, investors are bound to ask themselves, does someone already know the outcome of the study? I think the answer to that is almost certainly no, with the small caveat that in some blinded studies where the design is control vs active, it is sometimes possible for the investigator to make an educated guess as to whether the active is having any effect, for example when one of the outcomes is unavoidably obvious (for example mortality rate). For SAH on average around 40% of patients on standard of care die within 30 days and for the survivors c.50% will have long-term cognitive impairment, so if the investigator sees no perceptible improvement for these measures when looking at the combined blinded placebo and active treatments, they may come to the conclusion that the active treatment is probably ineffective, on the other hand if they see the mortality rate at 30% or lower and improved (lower) Rankin scores, they may conclude that the active is probably having an effect.
timbo003
26/9/2019
11:05
Nelson “ So what you are saying is that the company has been collecting data without knowing what data they are collecting?” No, I’m saying the data is collected independently and results revealed to the company as a later date (as in all these trials). Primary endpoint stuff like safety seems to be pretty much guaranteed from knowledge elf Sfx001 to date , but specific secondary endpoint SAH results and analysis isn’t
pennyfalls
26/9/2019
09:04
From RNS 28th August: .....All patients received the current standard of care, a calcium channel blocker called Nimodipine in addition to SFX-01 or the placebo. Nimodipine, first approved in the late eighties, offers a marginal clinical improvement only..... The clinical team is now focussed on the cleaning, validation and analysis of the large volume of data collected in this trial.... (Now let's go back in time) From RNS 18th March;... Following advice from clinicians and statisticians, and in the light of commercial considerations, the Company has decided to announce the primary endpoints (safety, tolerability and measures of blood flow in the brain) and secondary endpoints (relating to cognitive function) at the same time, rather than announcing them separately as previously indicated....1) Nimodipine only offers marginal improvement.2)The clinicians are doing the analysis.3) The clinicians advised for commercial purposes, 6 months beforehand. (After collecting all the primary and 27 months worth of endpoint data.
90005nelson
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