NNVC Keeping it real board for pro and con discussions Message Board

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Biotech / Medical : NNVC Keeping it real board for pro and con discussions

NNVC 0.943

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12:03 PM EST

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To: drkaz who wrote (229)	7/29/2015 12:22:19 PM
From: Rawnoc	of 326

SEYMOUR KNEW KILOGRAM-QUANTITIES WERE NEEDED SINCE AT LEAST 2013: "Because of the significant safety observed during the several animal studies designed to test the effectiveness of FluCide drug candidates in small animals, the scale required for the tox package studies was estimated at kilograms" (SOUCE -- NNVC's 2013 10K) sec.gov "This was before we found out that we needed 2.5kilograms of material. This only became apparent after the two initial animal studies were done by BASi. This amount was way beyond what we ever dreamed that we would need We had successfully scaled up from 100g/batch to 200g/batch that was all we thought we would need The preliminary safety studies were done early in the year by us in anticipation of the start of the tox studies later in the year when we had enough material This PR went out in April 2014 and the material wasn’t sent to BASi until September 2014 Strong safety observed in preliminary safety studies resulted in requirement of a very large quantity (200grams or so we thought at the time) for the Tox Package study. The 200gram/batch is what was initially sent to BASi and after their preliminary work, it was determined that they would need 12X as much for the large animals" (Seymour, July 28, 2015) siliconinvestor.com

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