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Wake up!

How Phase 1 Results Become Public

Phase 1 results are not required to be posted on ClinicalTrials.gov under U.S. federal law (FDAAA 801 and the 2016 Final Rule). These requirements apply only to “applicable clinical trials” (ACTs), which explicitly exclude Phase 1 trials of drugs or biologics (and small feasibility studies for devices).

Common Ways Results Reach the Public

Scientific publications and conferences — Many sponsors (or investigators) publish results in peer-reviewed journals or present them at scientific meetings. The International Committee of Medical Journal Editors (ICMJE) requires prospective registration of all interventional trials (including Phase 1) for a manuscript to be considered for publication in member journals. This often leads to registration on ClinicalTrials.gov even when not legally required.

Voluntary posting on ClinicalTrials.gov — Sponsors can (and sometimes do) voluntarily submit summary results. This is not mandatory for most Phase 1 drug trials.

NIH-funded trials — If the trial receives any NIH funding, the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information requires both registration and results submission to ClinicalTrials.gov, regardless of phase.

Other channels — Some companies voluntarily post summary results on their corporate websites, in press releases, or through other registries (e.g., WHO International Clinical Trials Registry Platform). The World Health Organization views public reporting of all trial results as an ethical imperative.

Later in development — If the drug reaches approval, limited early safety/dosing information may appear in the product label or FDA review documents, but detailed Phase 1 data are rarely fully public at that stage.

Tyke, all of the information and answers you seek are already in the public domain and the easiest way to search this material is to posit a question to an AI platform. I suggest that you ask someone here to do it and publish the answer for us all, alternatively read everything already published (as required by law) and form an informed view

Tyke, in the continuing quest to help us all form a balanced view based upon facts, I suggest you ask your preferred AI platform this question: "How significant is Kirkstall as a company in the organ on a chip market" and if you think it may help, share the result?

Tyke, your use of “we” suggests you have overlooked that IB(AI) is a holding company, and owns 100% of IB and now 100% of Kirkstall as well, ‘we’ in this context can only mean ‘we shareholders in IBAI’. IB did not “buy Kirkstall from Truetide”, but IBAI limited did. This is an important distinction as some here are implying that it was a kind of involuntary acquisition by the wholly owned subsidiary IB and even that it is part of a plot for Truetide to get hold of the IB IP. Remember also that the board of IBAI Limited comprises one independent NXD as well as MS the CEO of IB, plus TEB, and that it is the board of IBAI limited that makes decisions on group operations. Generally everything I comment about here is derived from existing public records but sometimes I seem to be the only one here who bothers to read in detail about our company.

****roaches are incredibly resilient survivors due to their adaptable biology: they breathe through body holes (spiracles), have an open circulatory system that clots wounds, can eat almost anything (including paper, hair, and even each other), possess detoxification genes, and have slow metabolisms, allowing them to live for weeks without food, days without a head (until they dehydrate/starve), and withstand significant radiation, making them tough to eliminate. the simile was with a company not persons, but i think the more intelligent here realised that

Tyke, sometimes the UK Regulatory requirements take precedence, it depends on the reasons for the RNS, mostly timing on the day is at the discretion of the Company

More paranoid nonsense, Truetide could not sell without notifying the market. The problem with many naive assertions I see here is that they appear to emanate from the Moronosphere.....

As I understand it, because the main operating business is located in the US, the text of an RNS will be the basis of a simultaneous press release Stateside, however as there is a 6 hour time difference, a simultaneous release with 0700 in London would necessitate a US 0100 am release. Today is Thanksgiving in the US, which presumably most of those here will be oblivious. My guess is that the enthusiasm for a 0700 release amongst some of you here is that it facilitates punting, scalping, day trading and other non investment activities - nothing whatsoever to do with serious motivations. If I'm wrong tell me why and how

Weekend wishes from Tyke, I hope all is well my friend

Just sayin'

Paladin (and others here), surely the 50m shares traded over recent days (and 14m traded over three days last month) dispel finally the myth that people stay away from IB because of the 'shenanigans' of TEB?

Maybe this will allow space for more intelligent and productive discussion to take place

What utter nonsense Janiax. 5.2 million shares traded is hardly killed off, and anyway the VWAP is 1.08p and actual spread is the usual 10% for this share, not the nominal spread.....

A few days ago, 14 million shares were traded. There was no discernible reason for this very very unusual happening. It’s still a mystery to me and presumably you also. But the preoccupations here are unchanged, TB, what does he do for the money, why no interviews, why no pr (though there are frequent RNS), etc, Meanwhile we are back to the scenario where instead of £10’s of thousands of value, there are a few hundred pounds and disproportionate changes in the share price.

Correct, I meant as a comparator, since barely any standard listed shares have such low caps

The preoccupation with TB. In the past couple of days 14m shares traded, we don't know why but evidently it was neither because of, nor in spite of 'TB's shenanigans'. Similarly the interview issue, seemingly the ostensible recent interest in IB came without the assistance of a recent interview with TB. Tyke to test your assumption about materiality, can you share an example of a real AIM business where shareholders returns was the direct result of a recent CEO interview. From my researches any TB interview in the distant past may have resulted in a short term spikette, quickly traded away by 'investors' who decided to use the opportunity to sell. Happy for you to prove otherwise naturally. In my very humble opinion the recent activity suggests there is still an overhang from stale bulls from the last placing, there seems to be a queue of sellers, some declaring here even.

***kroaches are more tolerant to ionizing radiation than humans. studies show they can withstand doses 6 to 15 times higher than what would kill a person—humans typically succumb to around 500-1,000 rads, while ****roaches have survived exposures up to 10,000 rads or more in controlled tests. my thought was that while the macro financial climate is increasingly worrying and i gave examples, there is an argument that ib could be like a ***kroach and survive whatever happens macroeconomically

i feel it in my water, am i alone? gold through the roof, up 39% in the last 12 months, and today the yield on the uk’s 30-year gilt climbed to 5.695%, its highest since may 1998, this is bigger than lab/con tribal slanging match. in these circumstances is ib a ****roach

Max you write "RNS suggestions CLN's" - which RNS are referring to?

Tyke, the sales process for any MRI software from any provider, is complex and typically involves multiple stakeholders within hospitals, including radiology leadership, IT teams, and purchasing managers. These decision-makers often require detailed clinical validation, workflow integration discussions, and budget justification before moving forward. Because of this, broad-based marketing platforms provide limited return compared to highly targeted approaches. The people you want to find IB via a Google search, aren't spending their day on social media, including LinkedIn which someone else suggested here. Frankly its very hard to imagine that insiders with very material involvement in the success or otherwise of the business, wouldn't have explored all the obvious options in great detail over the years.