Teddy,
Good post. Yes I agree. They have to be very careful here as one mistake and there is no second chance. (If PAR blow it then there is NO chance of TGA approval until AFTER the FDA Third Phase readout assuming that's successful). As you have mentioned, the more the data in the right format, the better their chance at getting provisional approval. I also think they could be waiting for the American data which would be of some ancillary evidence and data to add to the overall case.
Q4 ain't that far away...I am prepared not to get TGA Provisional approval until early to mid next year but anything sooner would be a massive bonus to us all.
Teddy,Good post. Yes I agree. They have to be very careful here...
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