Australian newspaper article, page-155

5. Listing Rule 3.1A – the exceptions to immediate disclosure

5.2 Listing Rule 3.1A.1 – the categories of information excluded
The first requirement for Listing Rule 3.1A to apply is that the information must fall within one of the categories
mentioned below:
 it would be a breach of a law to disclose the information;
 the information concerns an incomplete proposal or negotiation;
 the information comprises matters of supposition or is insufficiently definite to warrant disclosure;
 the information is generated for the internal management purposes of the entity; or
 the information is a trade secret.

Silviu Itescu is compliant - been told there appears to be sufficient data in writing- now quotes the FDA verbally reversing their stance and requesting Meso to refile.
On HC we have posters saying he was misquoted- paraphrased- made up- false reporting- blah blah blah. No denial from the company re headline news- no breach of ASX rules- colour has been added to official announcements- this bloke chooses his words carefully- has done so for years. Do you think he is going on the record with a false statement at the eleventh hour and potentially p off the FDA?

Mesoblast was asked for additional data, and went back to the FDA in January, expecting to be told what more needed to be done on the study front.

“And instead, what they said was ‘no, we’ve thought this through, and you’ve convinced us that the clinical data are very strong’,’’ Prof Itescu said.

“You’ve got enough to get approved for children – go ahead and file, and then consider how to take the product into adults.’’


Reg