Vivagel BV treatment and prevention, page-8

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RVR

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15/01/18

14:46

Post #: 30312923
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Originally posted by Edny ↑

Great topic - really getting down to business.
Here is an excerpt from Biotechcatalyst's notes from the 2016 AGM, posted 11-30-16:

Vivagel:
An NDA will be submitted to the FDA using the 2012 Phase 3 data and they think that the approval should be quick due to the GAIN Act incentivising new antimicrobial agents.
The change of the FDA guidance has changed the dynamics of the Vivagel deal making. They were looking for a pan-european company with complimentary products that would become a 'marketing partner' not just a distributor. but after the FDA change global pharma companies with womens health portfolio are interested. and as such negotiations are bit complicated and they are looking for a global deal. Jackie also said that they will look to recoup R&D cost, so an upfront of $15-20mil.
Jackie said to expect a global Vivagel for BV deal in the next 'couple of months'. Confident that it'll make them cash flow positive. She also said that the point at which SPL gets paid is when they 'send the product to the partner, not when the product is sold' so that revenue will be realised pretty soon after launch.
They said they have been hitting the TGA hard to expedite the BV approval. The TGA have been very slow and both Jackie and Turvey have been in contact 'with the relevant government minister' to help speed up the process. They said they really expected approval in aus before this and had planned on having it on shelves before christmas. This is not looking likely anymore and launch will be in 2017. They also said that it will be about 4 wks from approval to launch so quite quick. product is manufactured and everything ready to go.

A lot packed in here, more than we could possibly discuss. The relevant part to this thread is the implication is that SPL is manufacturing the product (Fleurstat). If so, then SPL has to recover the cost of manufacture as well as a profit. Raises questions about pricing, royalties, distribution fees, and so on.

More than a year later, does this excerpt still make any sense?

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So many times over the years I've seen Australian innovation virtually unrewarded, in comparison to the entrepreneurial research. Nimbler marketing and venture capital overseas so often leaves us behind.
I do hope it's not the case this time.....

SPL Price at posting: $1.38 Sentiment: Hold Disclosure: Held
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