We reached agreement with the Australian Therapeutic Goods Administration (TGA) on a plan for preparation of manufacturing and common technical documents to obtain regulatory approval for Zertane in Australia. The preliminary submission is expected to be made in the second quarter of 2013 and we hope to obtain approval in Australia in late first quarter or second quarter of 2014.
On March 11, 2013, we announced the FDA's acceptance of our Patient Outcome for Premature #$%$ (POPE) questionnaire, a modification of the questionnaire that was used in the two successful Zertane Phase 3 clinical trials completed in Europe. The acceptance by the FDA of the POPE questionnaire allows us, or a partner, to file an IND with the FDA for a pivotal trial of Zertane.
For those looking for a Zertane announcement I would guess AMPE is shopping. They are certainly in no hurry as they have the cash to get but Optina and Ampio approved. Would not think they would want to add another million or two in expenses right now unless they got a foreign partnership