In my opinion … I think several posters here today have drawn the correct conclusion from these trial results. That conclusion is that they don’t like being treated like idiots.
Why I think this … will take some waffle.
Several thousand trials produce results each year which are published in the medical / scientific literature. Does anyone think that the shambles that has gone on here is common-place. No-one being able to make head or not tail of what the results mean.
It doesn’t happen for a very simple reason.
When reporting trial results (in legitimate journals) you are required to comply with the international CONSORT standards. These standards have evolved over many years and represent the worlds best thinking of the elements that are required to assess the validity and strength of the trial results.
http://www.consort-statement.org/
Every biotech investor should be at least familiar with them and have a rudimentary understanding of the elements.
Now I can tell you no-one professionally would review the results presented by BOT. They are so non-complying with CONSORT they would tell you that you are wasting your time.
The two key missing elements here.
First participants flow. How many participants completed treatments in each group? This is your key metric of the quality of the implementation. Without this you are wasting your time trying to substantively interpret the results.
Second is the Per Protocol analysis that was specified in the trial registration.
This is the analysis excluding the people who dropped out or who did not comply with the treatment protocol (participants were required to keep diaries). If you got real fancy you perform what is known as a Complier Average Causal Effects (CACE) analysis. There are approaches here that you can use for teasing out placebo effects from vehicle effects from treatment effects.
All this information is sitting in a report in BOTs office. BOT has chosen not to provide the information that is required to properly assess these trial results.
It is almost as if the company wants to artificially generate speculation.
I imagine BOT’s social media monitoring agency reporting the numbers to Vince each day - 570 HC posts and 25 Twits. He rings the Board … wonderful news we are ranked third on HC for the fourth day running. Are they positive / negative posts someone asks … Vince chuckles … it doesn't matter.
So its racket … made more difficult by the rather arcane nature of clinical trials.
So I present for your edification a very simple heuristic that you can use to evaluate the strength of any clinical trial results produced by any ASX company for any product and for any human aliment.
It is a complete fix all; a bit like duct tape and WD-40.
Simply compare the degree to which the trial results are presented in compliance with those CONSORT standards. The better the compliance – the more transparent the results are - and the better the results will be.
Having made this judgment about compliance take a look at the market cap of the company producing them. If it is a MSB with a MC of $950m you want to see some quality for the price you are paying.
If you are talking about NTI with a MC of $2m expectations are lower. The inventor of NTIs product was found to have forged his PhD and the professor conducting their trial (a Chiropractor) features in the American Encyclopedia of Loons. The trial results are published in a junk science journal. While they are obviously complete rubbish in some ways it is nothing short of a miracle they got that far.
https://www.asx.com.au/asxpdf/20190327/pdf/443swglksldf80.pdf
http://americanloons.blogspot.com/2015/08/1448-ted-carrick.html
Where does BOT propose to publish these trial results would be a question someone with a mischievous sense of humour could ask.
By and large though you get what you pay for. But occasionally you will see a company appearing to be punching above their weight class in how they present their results. More often the other way round … as in BOTs case; punching below their weight class.
With BOT the final give-away I thought was the three “analysts” reports. The three analysts have qualifications in economics, accounting and finance. They wouldn’t know a clinical trial if it bit them.
They were unable to move management off script for one second. Not one iota of new information was produced. They simply paraphrased back (or more correctly parroted back) the company’s story.
Are the trial results so weak the bar is set at the level of your accountant? How on earth are they going to convince the FDA (or anyone else for that matter) about anything if this is their standard.
It’s almost as if BOT knows that If anyone provides just one additional morsel of information about these trial results their whole story could unravel. They sort of remind of a person “helping the police” who provides a “no comment” answer to every question the police ask.
Things will improve as the literacy of investors improves. Investor literacy has already outstripped the ASX skillset. Someone in the ASX skim read BOTs very positive trial result announcement and decided it was good to go.
Within a nanosecond of the market opening the share price had halved. Do the ASX understand how silly this makes them look. When it happens not just once … but with regular monotony.
Clinical trial results are not supposed to be simply advertorials. It is potentially a corrupting force that I don’t think anyone has a good fix on. Its good people ae waking up.
For the ASX there is a real simple solution.
In Australia there would be at least 1000 people who could assess clinical trial results with respect to their degree of compliance with CONSORT reporting standards (or at least a watered down version) in about one hour. Say $300 work.
The ASX would have lets say 100 companies reporting trial results each year. They could chose from three models.
One. Establish a list of certified assessors. The company gets an assessor to sign off that their trial results comply. Like a geologist is required to sign off on mining results. This is reported in the announcement – Blogs is putting his / her name to the results.
Second. The company self-assesses their compliance on a check list and this is reviewed by the ASX. This is the model used by medical journals. Authors have to respond to each element – a editor / sub-editor checks this off from the manuscript.
Third the ASX choses the assessor and gets the report back. If it fails the company has to keep redoing the results announcement until they get it right. And they pay for each assessment.
Many problems are fixed at once. Better transparency will promote better (and more informed) discussion of trial results. You won’t be able to claim “good” results which then see your share price halve. Ultimately you get the more efficient allocation of capital. We would all get smarter.
It’s so easy.
Waffle … end.
(20min delay)