Wednesday 12 March 2014

Roth Conference presentation

I took away a couple of important points:

Igloo is 90% recruited on its original topline estimates, but won't have enough PCR positive patients based on their estimates of differences predicted.

Related to that, the company seems to be estimating another season to recruit in Phase 2 then a year for Phase 3, so IND not until second half 2017.

That's a poor outcome in a strong influenza season.

Another year's delay to recruit about 100 PCR + patients is pretty poor. Not only in patent terms - a year's delay costs tens (?hundreds) of millions in sales/royalties. I don't have access to the statistical assumptions, so can't tell if a strongly positive clinical outcome could influence this decision. But I hope it does.

BARDA should only care enough to get an IND to FDA. I'm not sure how BARDA can assess what the FDA will think about the power in this Phase 2 based on recruited numbers and outcomes. I'm not even sure why 80mg was ever considered worth chasing, when 40mg is doing fine in Japanese registration trials and in post-marketing.

Looks like buying in assets is expensive at present, so no cheap deals on offer.

We need a deal here. Same as it ever was. Either LANI or Vapendavir or RSV - we need to strike some partnership deals so the market can start attributing some valuations, even if the timing might be uncertain.










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