Since PH3 trials, even in the 2008 CRL, the FDA has not asked for any additional major clinical efficacy or safety trials for Vitaros. Just minor safety studies, updated statistical methods on efficacy(done) and CMC data. CMC issues have been addressed through the continued manufacturing for approved countries.
Here’s highlights of FDA communication from conf. calls since 8/16
Aug 4 , 2016 –
US Vitaros resubmission strategy. …. These activities include completing several new non-clinical studies, compiling a Phase 3 trial responders analysis.
We have conducted additional toxicology and pharmacology studies to best answer key questions. We have engaged several world-class subject matter experts to review our data and to help us to address these deficiencies, and we have established a productive dialogue with the FDA.
We believe that the majority of the CMC or manufacturing efficiencies have been previously addressed as part of the approvals in Europe.
Importantly, we will rely on the strength of the overall body of data and evidence that has been the basis for approval of Vitaros in 23 countries around the world. It should be noted that the current body of data include several new supportive studies as mentioned above, a new responders analysis from the original Phase 3 clinical studies and the extensive post marketing safety data from Europe, all of which were not previously available to the FDA for review.
Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback
Nov. 18, 2016 Specifically, the FDA provided clarity on the requirements needed to address the deficiencies in the 2008 Complete Response letter to include suggested additional analysis of existing clinical and non-clinical data. The FDA feedback did not indicate that new clinical studies would be required for re-submission.
. “Importantly, .... we can further strengthen our clinical benefit section in the planned re-submission, using a methodology provided to us by the FDA.
AUG 2, 2017
The NDA submission contains data that we believe addresses all of the issues raised by the FDA in the original Vitaros complete response letter. The results of our successful human factor studies, as well as a significant amount of supportive data from the Vitaros global safety database, which we believe enhances the Vitaros risk benefit profile.
we have continued to have a very healthy dialogue with the FDA along the way and with the division
Nov 2017
As expected, we are in dialogue with the FDA on an ongoing basis with respect to the submission.
. As expected, we - as I said, we have had a dialogue with the FDA. They have asked for qualification on certain issues, and we provided that.
Leading up to the decision date, we'll continue to have that sort of working relationship with the FDA. And so far, it's been very positive.
AI
