Monday, January 26, 2015 10:19:38 PM
Pardon my "PG-French",.... but what the 'heck' do either of you mean by 'Cleaned'? Making terms up now?
I think you are going to be in for an unpleasant surprise here unless you are holding long.
This is somewhat incoherent. Yes - the TOX work must proceed at a BASi facility. Yes - they are going to be producing the materials they need for TOX (part 2) for BASi in the new facility. However - the production for BASi is going to start quite soon - so stating this is NOT going to happen in 2015 is probably just as incorrect here as in your previous point.
Not quite sure what you are getting at here,.... actually I suspect that we will see a progress indication of some kind easily within the next 3 months for the EB2 candidate(s) as the initial tests (cell culture assays) only take a couple weeks to do and do not individually take up that much space. Assuming they can be run in parallel for different EB2 formulations - that suggests that the company should have results from round 1 of testing a few weeks after testing is initiated at USAMRIID. 3 Months is time for a couple of rounds of such testing.
Again this false timeline is based on the false idea that NNVC will not be able to provide the required 2+Kg of Flucide before the end of 2015. As this assumption is very likely false - the conclusion that follows from it is also false.
However - expecting to see the results from the large animals (beagles) in a month or so is unrealistic. My guess - BASi won't have the Beagle testing data in hand before sometime this Summer.
The Clinical testing materials for the FDA cannot be produced until the facility is fully operational and appropriately certified. However the FDA equivalents in the EU and Australia have less stringent requirements that can be met before the FDA-level requirements.
However - since clinical testing in the USA is at least 12 months away,.... plenty of time to get the Shelton plant certified before then.
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
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