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drkazmd65

04/01/15 10:41 AM

#109625 RE: bloomvest #109624

You already know (or at least could make a good guess at) the answer for that bloomvest:

Clinical testing cannot start (neither here in the USA, nor in Australia or the EU where different standards apply for starting Phase I testing than in the USA) until after TOX is done.

In theory - when TOX is done, NNVC can apply to get Phase I testing started (Dr. Seymour has pointed to Australia) overseas.

Assuming that the most recent statement that the Shelton plant will be producing quantities of Flucide by 'early Summer' hold out, then TOX testing can restart on that time-scale (give or take).

TOX testing should take a few months at BASi post arrival of Flucide.

Assuming that no unexpected TOX results pop up - not likely as none have been seen anywhere else so far - Clinical testing could start overseas either late 2015, or early 2016. About the same time - the IND for the FDA can be submitted in parallel.