RE:RE:RE:Clinical Hold
fredgoodwinson wrote: Yes Vestor this is indeed troubling given the extent to which TLT sought to iron things out with the FDA beforehand.
In as much as a trial in the States has not been approved and therefore not commenced am I right in thinking that the FDA has no right or power whatsoever to intervene in never mind halt a current Trial approved under the auspices of the legitimate Health Authority of an entirely separate Sovereign State i.e. Health Canada?
The answer to this question is important to all of us.
I would think Theralase could use the info from the fda hold in order to make sure future studies are done the precise way the fda wants it done. Meanwhile the current Canadian study moves on. It's a forced do it right the first time thing maybe. Meanwhile its frustrating as people who could benefit are dying. Maybe doing a small study in the Caymans is not such a bad idea. Get some attention and inertia.