Are there any arguments against approving Blarcasamine besides for? -trial may be too small and may be a little too short -it was only a 2b/3 after a very tiny 2a
Seems that the arguments for approval vastly outweigh. The above can be answered with a confirmation trial after full approval. OLE can put some of that to bed as well.
Also for those that are more knowledgeable, it is my understanding that OLE data can be complied and gathered as patients finish making it a much faster process. Also, other measurements aside from the Adas and CDR can wait as they are less important at this time in terms of confirmation. If Adas and CDR are not what is expected, then the other OLE data will rise in importance and take much longer to flush out.
Either way, it is also my understanding that MAA is moving forward without waiting for any OLE data.
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