MSB Trading 2020 - a new dawn, page-8463

Type A meeting will almost certainly go ahead unless the matter is settled before hand. This is very possible as there is a fare amount of questions and answers before hand which is stipulated in the procedures.

From what I have read from the FDA website a rejection by the FDA of a meeting would give MSB the alternative to be heard at a disputes resolution meeting, this meeting is held at a management level above the current A meeting level. So unless the current level feel that they cannot resolve the issue themselves they will hold this meeting in a attempt to avoid the more public debate.

Being forced to a resolutions meeting would actually have some advantages for MSB as the outcomes are legal. None of "we may " or " It is possible "

The other possible reason for MSB not to go ahead with a Type A meeting would be if we had the ARDS results in hand . The FDA could simply advice us to lodge them in the current BLA and we will give you a answer within 30 days.

Please do your own research, this is only my understanding and should not be relied on.