Ann: MSB Annual Financial Results and Operational Progress, page-189

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    As far as I'm aware, the Office of Tissues and Advanced Therapies (OTAT- previously the Office of Cellular, Tissue and Gene Therapies) is basically a team that specialises in certain fields within the Center for Biologics Evaluation & Research (CBER), which is just one division within the FDA. There are other teams within CBER such as those who look after vaccines, and blood research.

    So OTAT will have the responsibility for regulating certain products such as gene, stem cells, tissues and other advanced therapies. So OTAT will regulate the products that fall within its mandate as well as advise CBER on technical aspects relating to these products. But ultimately CBER is the head of that division and the decisions are ultimately made there, with the consultation of its specialist divisions.

    So I don't think it's a pubic meeting or anything like the ODAC, rather Mesoblast have basically been sent to the team within CBER that actually knows what they are talking about from a technical perspective, and may have been the team who raised the initial concern. It's like when you call up Telstra and deal with the operator who doesn't quite understand your problem... and you spend hours explaining what your problem is, but if the operator isn't on the same level as you are technically.. then they may as well talk to a brick wall... but when the operator finally directors your call to the right team... it's like your talking to someone who understands exactly what your talking about and you can work together to solve the issue.

    So it may be a meeting or more than one meeting.. but at the end of the day MSB are now talking to the right team.

 
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