Replies to post #2983 on Insmed Inc (INSM)

[rod5247]

The way TRCA spins and misstates facts to make them appear more promising than they really are, this could be the case. Since EU requires MAA to be submitted for review at least six months ahead of validation for approval and submitted ahead of final orphan designation by COMP, I would expect TRCA could be looking for MAA validation by end 2006 and calling it approval which it is not final EMEA MAA approval. This would make sense because submittal of MAA is not noted by EMEA but MAA validation is publicly announced. An earlier post seemed to indicate TRCA was having problems with MAA. Time will tell but I don't think TRCA MAA could have possibly been validated so formal approval process has not begun. Once it is validated, it will take at least 210 days to get fast track approval. I see INSM way ahead in this process. MAA validated June and INSM expects approval first half 2007. This process fits EMEA published process for approval and INSM is on track and each step of process publicly verified. TRCA only has their own vaque statements without verification from EMEA. Will be interesting to see if I understand the process the way I think I do.