There has been all sorts of speculation here about the company avoiding the FDA, etc. I'd like to speculate that the company and all four regulators have communicated, and the company is doing what's been agreed on by all of them.
To begin with Sawston, without the EDEN, is set to cover the market in the UK, but not much more. Capability is being added at Sawston, so even without the EDEN it's possible Canada and/or Europe may come into play and piggyback on the UK approval. Finally, with the EDEN unit approved, the FDA will be added.
I know this is speculation by me, it's saying that what's being done is according the the plans by NWBO while working with the regulators. I'll still speculate that once the EDEN is approved there will be an arrangement with CRL to support at least all manufacturing, sales, cryogenic storage and distribution for the US. It might be for much more of the world. I say arrangement because there are many possibilities for how this may be structured, and arrangement leaves it open to whatever CRL and NWBO agree to.
I believe the company is doing precisely what they've intended to do, though it may be taking far longer than they planned. The four regulators are in concurrence with their planning and in time it will come to pass.
As for LP and the complaint that she's completely unseen, it's true, but I don't believe it will remain the case with a little success, namely UK approval, and a substantially higher stock price. I don't know that you'll be seeing her at every healthcare related brokerage or institutional conference, but I believe she'll be at a lot of them. I wouldn't be surprised if she'll get an invitation the the JP Morgan Healthcare Conference that kicks off the new year and is one that companies look forward to appearing at.
Gary
Bullish
