I would appreciate if anyone would have an explanation/idea and or comment:
By now it is apparently very clear all the management’s efforts in bringing forward the trial of ATL1102 is getting the approval from EMA in order to start trial in some (possibly more then one) locations in Europe which it is undoubtedly a good news but why the production of ATL1102 including the process of making it into an injectable drug has been granted to an American company located in California? This would add extra costs as they will have to forward (airfreight I believe) to European locations. It is hard to believe there was not any European company that could provide the same service in fact if I am not wrong when ATL1102 was eventually to be used for MS the production was given if I am not mistaking to a company located in Austria.
Could be a good strategy because it may mean they are very very confident to get the go ahead from FDA
even this latest set back. Any comments are welcomed.
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- Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD
Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-173
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