re: early look in.
Yes, I'm aware of this. However, I wouldn't read too much into it. They will be able to prepare SOME of the documentation in advance, which will reduce the amount of time needed to pull everything together in July 2009.
However, the FDA is extremely unlikely (infinitesimal probability) to accept any application as "complete" until all data from ALL patients is included. This means the final application can't possibly be submitted until (some months) after July 2009.
The early look-in may also help to reduce the FDA approval timing. However - they typically take 12 months now, so even if this is reduced to 6 months (which I'm guessing is optimistic), the earliest possible date for FDA approval is looking like around April 2010.
I'd say July 2010 would be more realistic as a "best guess".
What this means is that beyond June 2009, they will still need funding for an additional 12 months - at least. How much of this will come from sales revenue? How much from cap raisings? I don't know. As you say, debt is difficult in the current climate, but under "normal" circumstances would be my preferred route.
I'll be attending the AGM, see what happens. I'm not expecting any significant information, but I'm hoping to get a sense of the mood in the company.
Cheers,
BridgeBaron
VCR
ventracor limited
