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Nanotoday

10/01/13 1:30 PM

#74403 RE: Puffer #74398

Then they are producing the tox testing material in the new lab?

That IS new news.
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KMBJN

10/01/13 3:12 PM

#74428 RE: Puffer #74398

I think it is clear the back-ordered equipment is for the existing facility:

"While we have made significant progress in this scale up program at our current facility, certain key equipment pieces that we need are still on back order at present with certain vendors. After these equipment pieces arrive, we will need to set them up, validate them and then use them for the operations they are intended for. This continues to be an item causing delays in our goal of making sufficient quantities of FluCide for the tox package study and it is outside of the Company’s control."

They are talking about their current facility, and then in the same sentence say they need more equipment (at the current facility) before they can scale up the production process to get enough FluCide (produced at current facility) to run the tox package. This fits with what we've been told before.

FluCide for tox will be produced at current facility (when they get the equipment), no clean-room required. They say they've been working on this scale-up (plus some other things) since Februrary 2012, and it is slow going. They expected to have the equipment installed and tox started by June 2013 +/- 2-3 months, but they can't get the equipment. So delays, but if tox only takes a few months and drug not available for clinical trials yet anyways, it may not delay clinical trial start (yet).

FluCide for clinical trials will be produced at new cGMP facility in Shelton with proper documentation, sterile production, and manufacturing controls needed for human use. Of course need tox first, and new estimated completion date seems to have been moved from 2013Q4 to 2014Q1. Still could have drug for trials in Australia in summer of 2014.