I watched Jacqui's latest video with Tom P (CommSec) recently...

I watched Jacqui's latest video with Tom P (CommSec) recently and he asked her about timelines moving forward. For me, disappointingly there was zero comment on any progress relating to BV for Europe given we have had reg approval for what has felt like an eternity. With the total silence on distribution/marketing progress in Europe for a long time, almost like it's a taboo subject, I have figured in recent months that management must be looking to package BV for Europe with BV in the US. I figure they want to get BV approved in the US first which, according to an off the top of my head, semi-informed calculation while listening to her speak, puts regulatory approval in the US no earlier than say this time next year. I'm going by the Sloth calendar on this one given all experiences to date. Today's announcement doesn't change my view on that timeline.

Under 'Partnering' in today's ann the company says "Starpharma... also has advanced negotiations underway with a number of parties for other regions, including Europe. Global negotiations have been positively impacted by the recent developments in the US including revision to the FDA draft guidance for BV treatment, Fast Track status and the grant of QIDP designation for both indications."

It seems evident to me that Europe has always been tied up until we get US regulatory approval to provide a global deal that covers Europe and US combined. IMO management probably have their preferred company lined up but won't/can't get the deal done until US reg approval is finalised which also includes an extra 5 years of exclusivity in the US. The discussion with multiple parties could be a ruse, or at best, reference to some smaller players who won't figure in negotiations and final agreements until the major partner agreement is finalised. Just my thoughts. I see all this as being a year away from coming to fruition. Hopefully ANZ approval happens some time soon or we have no revenue to keep the whales from feeding on us plankton.

Since I have some time today I have transcribed part of that video interview as follows:

In relation to US FDA fast-tracking this is what Jacqui had to say to Tom's question on timelines for US approval.

Tom:
"Okay, so given that actual status, what does that mean in actual months or years?"

Jacqui:
"...the most important part is, when the dossier is submitted and we're preparing to make a submission in the next few months, they actually review it more quickly. So it goes to the top of the pile rather than the bottom of the pile and so what that translates to in terms of approvals is that you see more rapid approvals. So typically it would take 30% off the approval time. So you're talking about an approval time that is 3 or 4 months faster than would otherwise be the case."

Tom:
"Okay so when you look out to the next 12 or 18 months Jacqui what do you see as being the most important milestones for the organisation?"

Jacqui:
"Look, in the DEP program we're getting very close to the completion of our DEP Docetaxel trial which is currently recruiting additional patients in Guy's Hospital in London, so one of the leading London hospitals, to give us specific cancer types in that trial. So we're in the very final stages of that trial, so the last few patients going in. So completion of that trial. We're going to very rapidly move into the phase 2 trial of DEP Docetaxel and that's already very well advanced."

"On the AZ side, as I said, we've got an upcoming milestone in the very near future for that and that is progressing extremely well and we now have three active programs there with the potential for more programs to be added and we also have some significant progress , we're looking forward to taking our second DEP candidate into the clinic later this year, so DEP Cabazitaxel which is an important drug particularly used for prostate cancer and breast cancer. So we'll be taking that one into Phase 1 and we've had some great results on our other DEP program, so both our partnered programs with the two new targeted DEP partnerships, that we've got with major players in that area and also our mumble mumble (sorry didn't pick it up)."

"So we're looking forward to those, the prevention of recurrence trials in the near future and the reporting of those results and the commercial launch of the Vivagel and Vivagel condom products in various jurisdictions."

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While I know that DEP is the major product that will make the company I just find it staggering that Jacqui's continued public emphasis is research, research, research with such little focus on commercialisation - a lack of understanding of what shareholders want and need to know. Even condoms get more attention than BV. I love the DEP but I love to hear those words deal, signed, on the shelves, being distributed, revenue and payments. Is it too easy to go back to the whales for another CR top-up rather than actually commercialise a product? BV is 3+ months away from submission in the US.