Waiting on FDA response

On Dec. 16th the pre Investigative New Drug application for ovine GM1 was submitted to FDA.  We should have their response in 30 days. We are eagerly waiting to hear from them as this will essentially mean a green light for ovine GM1 to move forward.  This will lead to data collection for the IND application and submission so GM1 can move into clinical trials.  The new year holds more grant deadlines for NIH – NINDS (National Institute of Neurologic Disease and Stroke).  We continue to push ahead expecting new carrier lambs from cooperator flocks starting in Jan.  The likelihood of a 2015-2016 clinical trial is looking more promising. In December we met with Dakota Lamb Growers Cooperative at their annual meeting and added 2 more cooperating flocks bringing flock numbers to 12.  We should have many new carrier sheep in 2015 leading to many more affected lambs to treat HD in 2016.

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