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Empiricst1

03/14/19 3:43 PM

#258234 RE: petemantx #258232

The EU is not necessarily implicitly conceding that the US FDA is its equal in terms of well-staffed, quality reviews. For example, all medical devices made in the US now have to receive a new 510-type review in the EU. Just saying, working with them may be a requirement, not a cost saving thing. We'll see. but decades of naysayers about US bureaucrats, and foolish austerity measures have had their toll, and guess what FDA is. Same with the shrunken, weak SEC. Only to be feared by some small companies and easy targets. Do I sound bitter, yes, I am.

loanranger

03/14/19 5:01 PM

#258243 RE: petemantx #258232

"Who has any clue if it was ever submitted?"
We know "If" but we don't know exactly when.

It was a milestone in the 6/29/18 Aspire agreement. One would think that it would have been applied for by then. But just in case it wasn't....

From the September 20, 2018 PR headlined:
Innovation Pharmaceuticals Provides Corporate Update Highlighting Upcoming Milestones and Events
"A Breakthrough Therapy Designation application is currently under review with the FDA."


Obviously it was submitted many months ago.