Mesoblast stock(rock)-take March 2024, page-276

The Listing Rules require companies to immediately disclose information that a reasonable person would expect to have a material effect on the price or value of its securities.

Information is material if it would, or would be likely to, influence persons who commonly invest in securities in deciding whether to acquire or dispose of those securities.

Importantly, there is a line of authority suggesting that even if the information is supportive of a previously disclosed position, the company must assess whether any additional information that comes into their possession could materially affect investors’ decisions. If it clarifies or reinforces the earlier disclosure in a way that would influence the market’s perception of the company’s prospects or financial performance, disclosure may be necessary.

MSB has so far disclosed to the market that they anticipate a decision "prior to or on the PDUFA date". And then the company went on further to state "Mesoblast and FDA in ongoing interactions in relation to active BLA review" (per 29/08 announcement).

Has MSB sufficiently discharged its statutory obligation of disclosure by its use of the generic words "prior to or on the PDUFA date"? The answer to this question depends on what information is exchanged between the FDA and MSB, which would be privileged information unknown to the general market, and therefore retail participants in the market would have no avenue of holding the company accountable without knowing whether it has disclosed material information.

Obviously companies with professional BODs will adopt best and prudent practice to stand on the side of caution and disclose any information that might influence investor decision-making including those information that are only marginally supportive or relevant, we know from experience that unfortunately the current BODs falls far short of that standard and frankly looks scared to disclose information to the market unless the information is positive to the company.

IMO if the FDA has provided indications suggesting the possibility of early approval, whether likely or unlikely, this information should be communicated to investors with the appropriate disclaimers, rather than being kept as closely guarded internal knowledge.

For the above reasons, in my opinion, the price reaction driven by FOMO would likely be less significant than it could be with full and ongoing disclosure.