Evgen Pharma Share Discussion Threads

[moneymunch] 26/12/2020 12:41

Lol...bocker, there's humility for you, ha ha ha...Nobbygnome was incensed at my suggestion of early reporting , accusing me of misinformation....and now he tries to suggest that I was claiming early approval...ho ho ho....which was never the case, only the reasonable suggestion that Evgen could report early on interim results, which as we all know is exactly what will happen just as soon as the first 100 patients are recruited and assessed...I was right, he was wrong, but have I made much of it...no I have not, and he is the one who hasn't admitted he was wrong or shown any humility in the process. Gl....Exciting times ahead, with disclosure of the Solid tumour collaborator as well as potential news on the rest of the pipeline, including the potential Transformational game changing assessment on SFX-01's first 100 patients, news of which could land far sooner than a few obviously expect. :-)

[bocker01] 26/12/2020 10:31

Think you’re missing the point Nobby. But I’ll leave you to work out what that is.

[nobbygnome] 26/12/2020 10:16

Ok one more post and then I really will disappear again. You are going to be sorely disappointed if you think you are going to get efficacy figures from the interim analysis. The trial will either be stopped or it will keep going and that is all. Clearly the latter will rightly be seen as a plus but does not mean that the final result will ultimately be positive. It would just suggest that there is a chance it will be positive.

So the point is contrary to the popular view amongst some here; the only possible reason for the trial to be stopped is futility. That is the reality....

[bocker01] 26/12/2020 09:22

Nobby you were both very wrong about the early reporting and flatly denied it could happen. Knowing it now will, all can now speculate freely on when it may take place, what will come out, and from whom. Any idea that reporting on efficacy will be suppressed by those concerned is frankly laughable and defies common sense.

[nobbygnome] 26/12/2020 07:56

There is the chance of course timbo will be correct. Personally I expect the interim safety (note- not efficacy!) review a bit earlier than April but that estimate won't be far out.

I guess all we ask for is some humility whoever is correct when it comes to pass.

[moneymunch] 25/12/2020 22:41

Ps Timbo, you were incredibly reluctant to admit or agree , along with Nobbygnome's incessant and seething annoyance that SFX-01's Covid-19 patient trials could report early, to the point that you actually threatened to stop such speculation on this thread, yet it is exactly what is going to happen, just as soon as the assessment of the first 100 patients administered...and you still appear reluctant and somewhat stubborn to agree on any positive speculation that doesn't fit with your mates point of view..??? Gl :-)

[timbo003] 25/12/2020 22:40

MM, I think we will just have to agree to disagree on the likely timings and substance of the DSBM review, so I suggest we just park that one for now.

[moneymunch] 25/12/2020 22:28

Interim results January imho...positive reporting from DSBM will propel EVG's share price to multiples of existing value...watch this space. Gl :-)

[timbo003] 25/12/2020 22:15

>>>MM

Given that Evgen have stated on Dec 10th that the data from the study will be "potentially available in Q4 2021", that suggests the earliest date for completion of the last patient will be end of September 2021

The first patient should complete at the end of December 2020 and the last patient should complete end of September 2021, so it seems highly unlikely that they will have completed 100 patients and that DSMB will have conducted their analysis by end of January.

My own view is that the earliest that DSMB will complete their review is April, but I will be delighted if it is earlier.


Regarding the scope of the DSMB reviews referred to in the examples given above, they all refer to safety, but there is no direct reference to efficacy.

If the DSMB review in the SFX-001 study gives the green light to continue on to 300 patients, it will certainly be very encouraging, but it will not be possible to draw any firm conclusions other than there are no safety concerns and there is no reason to stop the trial based on futility.

The Company /Investigator could have opted to include a detailed interim analysis on unblinded data in the protocol which would give a good steer on likely efficacy but this would come at a cost (i.e. more patients required to acheive the same power and a significantly delayed completion date). As an investor in the company, I am very pleased that they are not wasting time and effort following that route.

[moneymunch] 25/12/2020 20:57

Here's what SFX-01's lead investigator managed just over a month in the recruitment to the Stop Covid trials, where patients had to be confirmed positive, 100 patients recruited in 17 days!!! and unlike SFX-01's trial, where patients will be recruited with pneumonia/Ards symptoms regardless of testing positive, which suggests recruitment to 100 could be rapid now that the trial is UP and running.....and since then we have a new variant or two that is running rife with the numbers going off the scale....winter is here and those affected by ARDS/Pneumonia will be escalating.....and so no shortage of willing patients imho....Gla holders....news very likely before many are expecting it... :-)

October 5th 2020

Tayside Clinical Trials Unit Retweeted
James D Chalmers
@ProfJDChalmers
·
Oct 5
Thanks to @NHSGrampian

for enrolling their first patient in the @NIHRresearch
urgent public health STOP-COVID study -


Teams across the UK are working incredibly hard to find new ways to treat #COVID19

.................................

October 22nd 2020

Tayside Clinical Trials Unit Retweeted
TASC Research UK
@TASC_Research

100 participants recruited to STOP-COVID19 #clinicaltrial nationally! A huge thank you to all the patients and research teams involved! @ProfJDChalmers
@dundeeuni
Oct 22, 2020·Twitter Web App

............................

11th November 2020

Tayside Clinical Trials Unit Retweeted
James D Chalmers
@ProfJDChalmers

200 patients now enrolled to the @NIHRresearch

Urgent Public Health Trial STOP COVID -Â
Testing a new anti-inflammatory treatment for hospitalized patients with severe COVID-19

[moneymunch] 25/12/2020 20:52

ps timbo...short on any detail??? ha ha ha ha...i could post dozens and dozens of similar DSBM assessments over the last year if needed Gl ;-)

[timbo003] 25/12/2020 15:10

>>>Briannewby and MM

It will be the Data and Safety Monitoring Board (DSMB) looking at the data after 100 patients, not the Principal Investegator or Evgen. DSMB's main objective is not to report on efficacy, see DSMB guidelines:


They may comment on futility if they have reason to believe that continuing the study is futile due to lack of efficacy, they may comment if they believe that the study is underpowered and requires more patients to have any chance of achieving significance for the primary outcome, but that is probably as far as they will go as far as comments on efficacy are concerned.


I have searched for recent RNS statements from companies which have had an interim DSBM review for an ongoing clinical study (google search terms: Data and Safety Monitoring Board and Investegate)


I cannot find a direct comment on efficacy in any of them, but here are the comments made in four of them (which seem fairly typical):


”The DSMB observed no significant safety concerns to prevent further dosing”

“the DSMB recommended continuation of the study with no changes to the protocol.”

“Data Safety Monitoring Board interim safety/futility analysis of 30 patients recommended study continue as planned.”

“The DSMB observed no significant safety concerns to prevent further dosing.”


I anticipate that Evgen’s comment on the DSMB review in the SFX-001 study to be similar (i.e. brief and short on any detail)

On possible timings for completing 100 patients: They recruited nine patients in the first two weeks, this corresponds to approximately 20 patients /month, so it would be reasonable to assume that they might have recruited 100 patients by end of April 2021 and completed 100 patients by end of May 2021, the DSMB analysis might take 2 weeks, in which case it would be mid June 2021 when DSMB report.

[briannewby] 25/12/2020 09:59

Easy MM, why so touchy? Said I thought it was worth a shot at this price. If it gets a good readout, then this price will look like an absolute bargain. I'm only going off other comments which have stated recruitment outside of UPH is slow due to the competition for patients (high number of trials), so it may not be as quick as some folk think. Very happy to be wrong (I have a holding), but if it takes longer so be it. Anyway, merry Christmas to you and let's hope for some great news soon.

[moneymunch] 24/12/2020 20:34

Anyways, what are you worried about, your leader has already stated that SFX-01 will never be approved for Covid-19 and is ridiculous to suggest that SFX-01 could be competition to SNG001...ha ha ha ...but he was seething and incensed at my reasonable suggestion that Evgen could report early on the current phase 2/3 Covid-19 patient trials...ho ho ho...and guess what...that's exactly what they will be doing on the first 100 patients. Gla holders...a stellar New Year ahead with any luck...SFX-01 is no shot in the dark...:-)

[moneymunch] 24/12/2020 20:18

Ps brainboy, how come you've made 2 negative posts on the EVG thread and literally 100's of positive posts on the snide SNG thread...ho ho ho ....Merry Xmas!!! ;-)

[moneymunch] 24/12/2020 20:11

Lol..well think again mate...Prof Chalmers other Covid-19 trial wasn't on it either, but 100 patients were recruited in 17 days from October 5th, and 200 were confirmed by 11th November...and that was for hospitalised patients tested positive for Covid, unlike SFX-01's trial that are recruiting patients with symptoms of Ards and pneumonia, regardless of testing positive or regardless of being hospitalized, and given the rapid rise in numbers, every chance that 100 patients have already been administered. Gl .....Tick Tock...;-)

[briannewby] 24/12/2020 19:51

Hi MM - I only ask because it may slow recruitment down if other trials granted UPH take priority. I do agree it's worth a punt at this price tho, just think getting 100 patients may take a bit longer.

[moneymunch] 24/12/2020 18:45

Not needed mate, the STAR trial is funded by LifeArc, and interim results on the assessment of the first 100 patients recruited could be very close....positive data will be Transformational for all concerned and propel SFX-01 into the the spotlight and focus of the leading potential therapeutic treatment for Ards/pneumonia associated with Covid-19...Fill ya Boots...Gl :-)

[briannewby] 24/12/2020 16:49

Am I right in thinking the STAR study was not granted urgent public health status?

[moneymunch] 24/12/2020 16:16

Well done Boris, one less thing he has to worry about, and the UK is now set for another exciting chapter in its illustrious history...On and UP!!! :-)

Ps Merry Christmas to all...:-)

[amaretto1] 24/12/2020 07:46

Go long sterling !!