Hi Happy!Days!
Yes an update newsletter is due any day soon and would be very welcome.
Whilst most of the recent chatter on HC seems to have been mainly about a) lack of information b) ArTiMist c) SUD 003 and d) Zolpimist. However I am interested in an update on the status of SUD001 (migraine) as this is just as much a biggie and headline grabber as SUD 001 (Viagra). It should be noted that SUD001 is not limited to a single gender and hence has the potential of 2X market size of SUD003, which is male focussed......but at least the excuse of "not tonight dear, I have a headache" may well be a thing of the past.
Well what is the current status of SUD001?
6th AUGUST 2015 saw the ASX Release POSITIVE RESPONSE FROM FDA.
The FDA keeps us on track to commence our pivotal PK study of SUD 001 in early 2016, which is designed to support the submission of a NDA (New Drug Application)in the USA by thr end of 2017.
OCTOBER 2015 NEWSLETTER
Starting the pivotal study in the first half of CY2016 and it will strengthen the negotiating position with prospective partners by quantifying the cost and time to get SUD001 to market.
17th NOVEMBER 2015 AGM PRESENTATION
Successful meeting with FDA in July 2015 regarding pivotal plan.
I hope that this plan has been somewhat firmed up by now and hopefully there will be a timeframe put forward with the attached budget for the trial. However it is just as important to now how the trial is being funded....from SUDA in-house funds? A CR? A potential partner? Or even from left field, AMAH (Association of Men Against Headaches.)
..kippax
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