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Saturday, January 25, 2014 6:39:57 PM
This largely includes expansion that already happened last year to move along both L and Direct and other experiments, and we also knew that even without news (or news of a 'continue') there'd be trial expenses for another year with very little cash on hand and lots of debt already owed to Cognate.
Remember that while these trials are going on scientists don't just twiddle their thumbs, they're working on incremental improvements and new processes and whatever else they might need in the pipeline to follow up a success or failure with something better, and that too has to be a capability built into anybody's facility.
Also remember especially with the younger, smaller trials like Direct that it can't just be kept in-house and run off the side of Alton's desk until commercial scale is absolutely required. The regulators require that the manufacturing used in the trials which justify an approval is the manufacturing used upon approval. If you change methods/environments/etc., you have to get that (re)certified and often even start some new trials just to prove it won't make a difference in safety or efficacy. That's a huge cost in money, in time, and in more money because time is money.
My point is, this isn't about the announcement in January versus February, it's about the trials that were accelerating or started last year just so we could get some news in January and February. The reason it was formalized on the 17th was because of the third party agreement resolution on the 10th, but we already owed Cognate and even after the 17th kept the option to strike a better deal.
Never mind whether we get any news this month or next, we needed the existing part of this just to get as far along as we already are. Secured cost of materials is all the more essential if there isn't great news, because the costs will continue while cash will be harder to find. The terms of this deal go hand in hand in justifying Cognate's investment and risk-amplification. We might not have gotten them to accept equity for invoices without also the incentive of a larger contract and up-front payment for their resource devotion and specialization.
Furthermore, just because they have the capacity doesn't mean northwest has to use it (in the scenario that things go badly), while having the option in case of good news means the company can move fast and not lose time to competitors with deeper pockets and established facilities (to say nothing of patent terms and larger trials being required to prove superiority of the newer more efficient methods and so on...) We already knew there would have to be more shares issued publicly or privately just to pay for the things already happening and that should have been factored in. I think that share count is trivial compared to the potential dilution if we actually end up using the full extent of Cognate's future capacity in the long term, which is where the conversion rate concern comes in, and like I said before that much more relevant component of this arrangement isn't really worse than a non-affiliated partnership where NWBO does all the real work (R&D) and big pharma takes the majority of the profits, or an all-cash deal with a vendor who has no obligation to serve us (leading to public dilution instead of private dilution and additional risk factors from a business control perspective).
You have a point that to the extent such an expansion is superfluous, the company could keep waiting, I'm just not convinced it was superfluous, or that all justification also qualifies as reportable news, or that there isn't something to be said for preparing commercial viability when commercial viability has been an even heavier anchor for this industry than technical viability (e.g. the cost of provenge). They have to be very careful with announcements, especially considering some sordid history of shooting PR from the hip and also to avoid annoying regulators - but that doesn't mean the information is irrelevant to planning.
Your scenario sounds better, and in fact is a lot better if it could guarantee to play out that way in time, but what if cash was needed before then? Take some shares off the shelf at emergency speed for what, $4, maybe less, and give them to someone with no fiduciary obligation to serve NWBO? Risk Cognate withholding the next dose until someone pays the damned bills? Seems irresponsibly risky to me. Risk patients queuing up for months after approval before we can serve them (and make money) while another cGMP facility is built out and certified? That's also a kind of risky albeit far less relevant for now.
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