Tuesday, January 27, 2015 11:37:16 AM
Your first clause is likely at least partially correct (up to the parentheses). I suspect that some 'drops' have been produced - but only in test runs with poor quality control that cannot be used for anything clinical or preclinical.
Your second clause is (as you admit in your own parenthetical phrase after it) conjecture - at best.
My thinking is as follows on this topic.
The new equipment (the larger batch 50L apparatus) is likely not going to be successfully scaled up until sometime in Q3 - which jibes with that of your alleged sources. This is why there is no likelihood of there being Clinical testing until at least Q3 for Flucide. These need to be up & running - with stable SOPs - and process certification has to be ongoing.
They do not need fully certified batches to continue with TOX testing. To continue to state thus is to perpetuate myth. They won't need the full certification until they are going into FDA-approved clinical trials. Australia and some parts of the EU have different standards and clinical testing can be begun while certification to meet FDA standards is underway.
The old equipment (the equipment they have successfully scaled up to at least 200 g batches in already) is reportedly being moved into the Shelton plant currently and will almost certainly be running before the end of the current quarter. That's why I state categorically that:
Those who continue to incorrectly push this false timeline of it 'won't happen in 2015' are going to find themselves somewhat surprised over the course of 2015.
I suspect you actually are not - but that you might end up so.
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
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