Hi Rykster. can you tell me how RCE have pulled out of the FDA process? My understanding is that a proposal can be put to FDA at any Point during trial process as long as data is formatted as required by FDA.
I believe rce are using CMAX lab for iv trial with Parexcel doing the data collection.
Both groups are listed as being capable to formulate data to required FDA standards. the intention was to do the initial trials here in Australia where it is easier and cheaper, then to present the data to FDA on successful completion of trials at maybe end of phase 2 trials. Do you know something different to this?
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