The 8k announced this morning states that once the Ampion IND is accepted which is expected to be fairly soon because it is based on the FDA's recommendations, the Phase III trial will commence.
There will be two trials of 800 patients each.
One of the trials will include 320 patients and has the possibility of substantially reducing the number from 800 that will most likely result in significant cost and time savings.
This announcement enhances the phase III trial and does not protract the time or add to the cost.
The reason for the 320 patient run-in study is to evaluate Ampion's performance if it is increased from 4 ml to a more common dose currently used for Synvisc or steroid injections.
The CRO who ran the phase II trial for Ampion says that results from the 4ml injections were the best results of any drug they ever performed trials of in their 25 year history. Ampion was effective in hours, not in the 84 days as some suggest based on the company's presentation indicating the 84 days that is misleading.
The company is now waiting for the FDA's acceptance of their recently filed new IND.