It has been some time since I put serious input into the...

It has been some time since I put serious input into the Starpharma forum.

So here goes.

More than a decade ago Starpharma started on a journey to develop VivaGel^™ BV formulation with active ingrediant  SPL7013

Conducting nine trials up until now and bankrolling these tests to the tune of over a AU$100 million with the knowledge of enormous untapped demand globally , any sane person (including those on this forum),would think the strategy of company to be sound.

We had a SPA in place.
We had Fast Track status in places
We had Qualified Infectious Disease Production designation in place
We handed the FDA a 110,000 page NDA document - which was a culmination of many years work
We had open communications with the FDA......so there would be no surprises
A couple of weeks before PDUFA announcement we had a licensee who was going to put AU$28 million upfront on approval of FDA for the NDA in Starpharma's bank account and the balance of AU$114 million in milestones and inflection points

So what could go wrong

Nothing

Starpharma management were so confident of a positive outcome. I was 100% confident of a positive outcome as well as I am sure..........many of the forum participants

All that has been presented on this forum into the why's was conveyed in announcements (the emails forwarded to posters recently was also presented in announcements......all it has done is reinforce the previously transmitted news)

There is no doubt in my mind as some have put on this forum.......the goal posts have changed

It is so obvious

Remember staffers that were working on the NDA......some had left and new ones had entered the arena. Why is not important....

So the biggest question I ask myself over and over and over again........if there was open communications with FDA and Starpharma over the years in regards to an adequate NDA.......

why is it at 5 minutes to midnight that the FDA say they require confirmatory clinical data (which may not necessarily mean a new clinical trial) before approval

Like a poster has previously said......Starpharma had plenty of experience of what to expect from the FDA.......the board are not novice at this.

All the i's were dotted and all the t's were crossed

Posters have said something fishy is going on here and it is not the smell coming from persons with BV