"Phase 2b/3" clinical is clinical development shorthand for Phase 2b/3 PIVOTAL trial i.e. FDA appears to have accepted the phase 2 from the Imperial College of London to support accelerated clinical development and subsequent regulatory approval. This is highly significant.
Now that RAD appear to have had a successfuo pre IND meeting with the FDA this puts $44m RAD ahead of $188m market capped CU6 and perhaps only 15 months year away from seeking regulatory approval for pivalate.
In addition, the first patient for RAD301 should be imminent (this is a high probability trial given the work to date and it should show further signs of effectiveness) and we should be getting top line results from Lantheus Phase II Pelican imaging study into RAD204 shortly - remembering RAD-Lantheus have a data sharing agreement on the molecule. Now that Lantheus has entered the lucrative therapeutics market, there's always the potential for some corporate activity if their trial is successful, rather than derisking RADs asset without exposure to the upside.
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