RD, I'll certainly admit that I believed things would happen quicker, and frankly I've been in biotech's long enough to know better, but I'm simply an optimist. I still believe approval could come any day and that the UK regulators simply couldn't meet their 150 day goal. In reality if they do finish shortly they'd be spending essentially the same amount of time as the FDA, which sets their PDUFA date 6 months after accepting the BLA or NDA.
I'll grant you the company has occasionally missed on guidance, but most of the time it really hasn't set specific targets, most companies don't do predictions more specific then which quarter, or even half of a year that an event will occur. It's unusual that a company specify a month and sadly miss it, they'd have been smarter to have said this quarter, and they did file in the quarter that they expected to file over a month earlier.
People who consider a biotech failing each year they fail to gain an approval are clearly fooling themselves. Blockbuster products often take two decades or more from genesis to approval. In some cases a product can be in preclinical development for over a decade, almost nothing is known about it at that time. I won't say that with unlimited funds DCVax-L couldn't have been developed faster, but I don't know of any biotechs with no approved products who have unlimited funds. I suspect that most similar companies would have taken this long, or longer, and some may have gone belly up and had nothing to show for it.
I'd love to see approval next week, but I'd be satisfied with any time it's approved.
Gary
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