If you would like to ask our webinar guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund a question please submit them here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
I agree that clinical significance means nothing without statistical significance, I'm well aware that you can’t have the former without the latter. I also agree that that when considering this study’s primary endpoint which involved both bowel habit and abdominal pain, only the combined group was statistically significant.
I didn’t play liberal with my use of terms though. If I’m guilty of anything it’s that I didn’t specify that I was specifically referring to the additional analyses that they released earlier this year in May where they looked at bowel habits and abdominal pain independently. Blautix resulted in a statistically significant improvement in bowel habits, both for each group individually and combined. Furthermore, it had a positive effect on abdominal pain for both groups individually.
As noted in the same presentation…
FDA, Irritable Bowel Syndrome - Clinical Evaluation of Products for Treatment (2012). “A drug can be specifically developed to treat only one of the major signs or symptoms of IBS [abdominal pain or bowel habit], which should be identified as the primary endpoint in the clinical trial. The other key efficacy endpoints should be assessed in the clinical trial as secondary endpoints. Demonstration of significant and clinically meaningful changes in the targeted single endpoint could serve as a basis for approval, as long as the other important symptoms or signs have not worsened on treatment.”
In other words, for the phase 3 study they can target bowel habit only as the primary end point and if they see the same results as the additional phase 2 analyses for bowel habits and abdominal pain individually showed, that will meet the criteria.
Boonco ... with respect, that is not true. The terms that you use so liberally mean nothing without statistical significance. Blautix has a very tenuous statistical significance in the combined group from the readout RNS. Note that its not significant in either of the IBS classes individually.
My point to PhilGekko was that be careful for what you wish for, anything tenuous like that again and it will tank the share price far quicker. Music to Sang's ears ofcourse, as he has a magic money in the garden for endless top ups :-)
I'm pretty confident you know the answer mumbo just as you know that considering p value in isolation isn't good practice.
Clinically significant, clinically important, clinically meaningful - choose your term it's all the same.
"clinical significance"...... what would that be then?
"As an example I read their Bleautix readout from last year, and did the statistics, moving around one or two patients here and there can make a big difference from being "statistically significant" to not. The statistical significance is very tenuous."
and yet the question of clinical significance doesn't seem tenuous, go figure huh.
considering we are only five days into autumn which has a duration of 92 days this year I'd be caqlling the whole of Ociober "early autumn" the rest being mid and late. Can't do anything about the qdefinately bit.
Mumbo_Jumbo... it's called Blautix. Glad to hear you've done some statistical analysis of that data readout. Good stuff.
As an example I read their Bleautix readout from last year, and did the statistics, moving around one or two patients here and there can make a big difference from being "statistically significant" to not. The statistical significance is very tenuous.
Frankly, i think most of us would consider being green boxed a badge of honour!
Phil - be careful of what you wish for......
People invested for over a year and 30%+ in red (I am one of them) are not some dumb ass day traders. It hurts to bleed 3-5% daily because the company has no gunpowder to attract IIs and mitigate the effects of the distressed seller tanking the SP.
I still believe this company could become the 'Tesla of biotech' - but for now it would be good to stop the bleed. We need results.
And don't bother replying as chances are you will have been green boxed.
There's about 5-6 people that post useful stuff here. I have filtered everyone else
Am I really the only one here hoping for it to drop even lower?
I really don't think 4D are that concerned about some dumb ass PIs that are upset because they didn't make a quick buck
The BOD need to remember that they have a responsibility to promote shareholder value. There are many forms of communication available to them: they need to regain the will to keep shareholders informed.
Hey Phil, agreed fully.
Because of the nature of 4D projects some delays in producing data from trials are, within reason, understandable. Yet, June became late summer / early autumn and H2 in the recent presentation became end of this year, beginning of next for Keytrudea + 0518 trial (Duncan Peyton). Still fine but we should have a progress report. The SP is lower than it was before the presentations which demonstrates that the info provided hasn't been substantial and was largely recycled material. You are right: with some positive news the buyers would have largely outnumbered and outweighted any seller. Or, if data are inconclusive to date, we should still know.
Buy the dip and hold simple.
Where is our update?
I am a very patient man but don't need any 'fireside chats' with Merck... need bloody data for this bleed to stop.
Ehat we heard from the company recently does not qualify in my opinion as an update.
And don't care about the distressed seller. When data is good for every seller there are 3 buyers.
4D - wake up.