Hi Southoz
The issue about FDA approval of the trial seems to be one of semantics. CAN004 was previously approved, but the protocol has changed in terms of the number of patients to be recruited and more importantly, the criteria for inclusion and statistical endpoints. As such, I'm assuming it would be simply a matter of the FDA effectively rubber stamping the new protocol.
In of itself, this is not a particularly big deal, although I agree it seems some appear to be making more of it. Essentially it just means that, along with sign off by the local authorities (e.g. Belgium) and the trial site Ethics Committees, PRR can begin recruiting patients for the trial. Just another step along a long road.
The pump and dump activity of late? I think that's simply traders doing their thing. The pattern seems to be pretty well established.
I am more encouraged by Neopharm's confirmation of the License Agreement, especially after they've had an extra 3 months to do their due diligence. The additional funds they provide will be nice too.
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