Ann: Prima BioMed's CVac granted Fast Track D, page-37

re: Ann: Prima BioMed's CVac granted Fast... Reflections thru a whiskey glass...

As the dust slowly settles on todays's activity there's a lot to mull over given both the FT announcement and the analyst research piece.

Fast Track designation is a nice thing to have under the belt. Essentially it doesn't guarantee a result, but it does make the process easier. It won't reduce the cost of trials as they are event driven (number of patients is the cost driver) but it's like the FDA putting out the welcome mat and saying "Come on in and let's talk".

peaceAKKI made the point that Breakthrough Therapy Designation is the real game changer and I tend to agree. That allows for a significant shortcut in the commercialisation process. It means they almost skip an entire step as the Phase 3 trial can be conducted when the product is already on the market. Some time ago I asked Matt Lehman about BTD and he was understandably cagy in reply but he did say it was something they were working towards. My sense is they'd have a strong case to apply for BTD based on good interim results from CAN004 so around mid 2015 or thereabouts. FT status is the obvious pre-cursor.

I reckon there's a wealth of clues to be found in the Edison paper, including some ballpark forward sales estimates and production cost/gross margin projections. I'm going back and re-read that to pick up the minutae.

Looking forward to see what the US market's reaction to all this overnight. One thing I can predict with complete confidence, SP volativity is going to be our companion for some considerable time to come. Traders will do their thing and I'm OK with that, as long as it's not a case of blatant manipulation.

But now, it's back to the scotch bottle. TGIF
Cheers all.
K