Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
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Noix,
I appreciate your comments regarding mystic meg, however, we invest, when we have done our research, in the hope that our investment to increases in value. By the very nature of buying shares we are predicting that they will rise. Otherwise its a pointless exercise. You in your own mind I am sure have a figure? We all do.
I have read all the threads on this BB and many analyse the science to death. Thats fine if thats your bag.
I want to know what the science means for the company and in turn the effect on the value of my investment.
I will stay positive, and on the basis that 4d compared to pharmas that have had lesser results there value has increased.
I, like many of the others bring a positive attitude. And yes we still have free speech....just.
No offence
Yes exactly, Noix. We are dealing with probably common root cause(s) for ibs as a whole which Blautix seeks to address and ameliorate whereas conventional treatments are trying to address an often moving symptomatic target. The symptoms are undoubtedly an issue for sufferers but actually they are also indicators of an underlying problem. Blautix could be described as an attempt at providing proper medicine ie help with the underlying problem ( and then effectively as a byproduct help to tackle the symptoms)
crusty pete
"I would have thought that it would be fairly obvious to the "patient" whether it is "C" or "D"...... :0)"
With respect you have missed the point. There are many IBS sufferers whose symptoms alternate between C and D. Hence a treatment that addresses both types with the same dosage is a major step forward in this sector. 4D are saying that Blautix does this and that's why they see it as a one stop therapy for doctors to prescribe.
Guys we live in a free speech country - just - but can we please cut out the mystic meg predictions for thye share price because it brings nothing to the party. I'd have thought that people would have learnt that lesson 2 weeks ago.
I would have thought that it would be fairly obvious to the "patient" whether it is "C" or "D"...... :0)
In a recent interview management also pointed to the benefit of a therapy that worked with c and d. Namely a general practitioner can offer therapy directly rather than needing to send you to a specialist to identify and classify whether its c or d. Or resend you to the specialist to repeat should your symptoms start to change. If it gets good significance at phase 3 it should take over as the key product on the market for both this reason and because of the lack of side effects.
As the Company has stated, they see this as a one stop treatment for all tyes of IBS and as it will be the only product in the market that addresses both types, it can be confidently prescribed by doctors to those people that alternate between C and D.
Slide 10 on the webinar shows the comparitive with the other IBS products now to market at the same stage of their development ie Phase 2 trials :
https://www.4dpharmaplc.com/application/files/7216/0201/7566/4D_pharma_-_Blautix_BHT-II-002_Ph2_IBS_Results_Oct_2020.pdf
Could it be that DDDD will design the pivotal P3 trial to focus on IBS-C/D, given these latest results?
Thanks for this thread, very helpful.
Michael
On the 15th October I posted this as part of a comment on the results, which was subsequently questioned by a couple of posters:
"As many of us have been at pains to point out, the market interpretation of the results was a mis understanding of the numbers. Had the IBS C and IBS D individual cohorts been of greater patient numbers the "not statistically significant" label would have lost the "not" and the market reaction would have been completely different.
Just to prove the point, the summary of all the results, including the example given by 4D to you, is as follows:
IBS C/D combined response rate of Blautix 24.1% vs 17.5% for placebo, so Blautix 37% better efficacy.
IBC C response rate of Blautix 25% vs 17.1% for placebo, so Blautix 46% better efficacy.
IBC D response rate of Blautix 23.4% vs 17.8% for placebo, so Blautix 31% better efficacy."
The Company in its latest response to you have said this:
". For the IBS-C FAS this was 25%/17.1% = 1.46 = 46% over placebo; for IBS-C/D combined FAS 24.1%/17.5% = 1.38 = 38% over placebo; in both EEAS groups the effect size over placebo was enhanced. This we believe is a clear and positive outcome, particularly in IBS where the margins for currently available therapies vs placebo are not dissimilar (and sometimes smaller)."
If those two posters disagree with the Company, I trust they are no longer invested.
I’m guessing we should be expecting some RNS’S before the presentations ? Will there be market sensitive information in the presentations?
(Post to be seen in conjunction with one just posted)
"Hi,
FAS is the Full Analysis Set, all subjects randomized in the study
EEAS is the Efficacy Evaluable Analysis Set, which includes all the FAS patients who completed the full 8-week treatment period without major protocol violations deemed to impact the assessment of efficacy; these patients were excluded in an blinded review i.e. before anyone knew if these patients had received Blautix or placebo.
40 patients from the FAS were excluded in the EEAS
Having completed the full treatment period and without major protocol violations deemed to impact assessment of efficacy, clearly the EEAS is the more representative of the true activity of the drug. FAS is required to be reported as per the trial’s protocol
Hope that answers your query. "
When looking at the numbers in the presentation (as opposed to the RNS), it seemed to me that TWO groups (not ONE) i.e. IBS-C and the aggregate of IBS-C + IBS-D had achieved statistical signifiance at P=0.1, in other words 90% confidence that 4D's drug was superior to placebo by the difference stated. In the case of IBS-C statistical significance was borderline whereas the aggregate group comfortably passed . However, at first sight, that seemed to be at odds with the RNS so I wanted to check my understanding was right: posting the answer from 4D on Friday as others may find it as helpful as I did.
RESPONSE FROM 4D:
"When the Phase II trial was designed the statistical analysis plan was based on 1-sided Pearson chi-squared test (don’t mean to overload you with statistical jargon, just for completeness) at a significance level of 0.1. Some retail investors have expressed some confusion about the 0.1 significance, as many are used to seeing 0.05, however this is not uncommon for this kind of signal finding Phase II trial.
So, in the IBS-C EEAS group Blautix vs placebo was statistically significant at p=0.097, i.e. <0.1. And yes the IBS-C/D combined group EEAS at p=0.037 comfortably met our pre-defined 0.1 significance level, as well as the conventional wisdom if you will of 0.05.
To reiterate two important points. Firstly, the IBS-C patients are the same as those in the IBS-C/D combined group, and analysis of statistical significance is heavily impacted by sample size."
Secondly, this was a Phase II trial to generate a signal and additional clinical data to guide Phase III, and not a pivotal trial which is ‘make or break’ on 0.05 statistical significance, though we are of course even more encouraged having met this. While p values are an important aspect of interpreting scientific data, in this relatively small clinical trial (compared to pivotal IBS trials) we believe the key and most clinically relevant figure is the relative response rate compared to placebo. For the IBS-C FAS this was 25%/17.1% = 1.46 = 46% over placebo; for IBS-C/D combined FAS 24.1%/17.5% = 1.38 = 38% over placebo; in both EEAS groups the effect size over placebo was enhanced. This we believe is a clear and positive outcome, particularly in IBS where the margins for currently available therapies vs placebo are not dissimilar (and sometimes smaller).
Hope that has clarified your query, thanks for getting in touch"
PS. Another post will follow soon clarifying the FAS, EEAS definitions and why RNS seemed to me initially to be at odds with presentation (they were not as it turns out).