PM,
A Phase 3 trial really isn't successful until the product in trial is approved. In the case of NWBO, that really can't happen until they can commercially produce the product and regardless how great the data is, the regulators won't move until commercial production is approved.
No BP or other investor is going to pay a large multiple of the current price because that's what the company's asking for in a partnership. Clearly such a partnership will move the share price up, essentially to near the offering price, but the shareholders in the offering company won't accept their company paying a major multiple of the current share price. A hostile offering could be made, one which the management clearly doesn't agree with, and that too would drive the share price up, even if it's not accepted.
If today Merck offered $1.50, roughly twice the current price, for 10% of the stock in the company, the company would reject it, but we'd be trading at or near $1.50 overnight. If they then offered $3 and had it rejected we'd be selling at near $3 overnight. We could continue that until they offered a price the company would accept, but it's just not the way most companies will operate. Merck knows that once sufficient information is available NWBO's share price will reach at least half of what they already know that NWBO wants for either an equity partnership, or buyout. Whether it's a gentleman's agreement to formalize their offer once they approach that share price, or it's formally agreed to, it won't be finalized, and cannot be announced until the terms required in the agreement have been met.
Let's allow NWBO to work on building the share price by their actions. Certainly the suit may be something which drives the share price up as they prove that others have been working to keep it down. The findings should prove that the company's shares should have been higher, but they were illegally being manipulated to keep them down. I believe we're far from the only company who's shares are being manipulated in this way. The SEC isn't policing the securities industry unless forced to do so, and they're especially lax when it comes to OTC stocks, but it's not that much better for smaller Nasdaq companies, like IMGN, my other major biotech holding.
I believe that NWBO will have little problem gaining approval from all regulators once commercial production capability is approved. It's fine if the U.K. accepts it for a facility that does it manually in a large number of small cleanrooms. The facility required for approval in the U.S. or in other major populations would be many times the size of the Sawston facility and clearly isn't the path the company's choosing. Sawston will clearly be converted to using the FlaskWorks units once they're approved, but until that time can meet initial U.K. demands and hopefully will be approved shortly in the manual production mode of operating. I would guess that each small cleanroom that can only produce one batch at a time will be converted to a cleanroom that is occupied by multiple FlaskWorks units, perhaps 10 or more, each producing a batch in the same time, or less, than it takes to produce a single batch manually. Computers will track and control what's happening in each of the FlaskWorks units, and fewer people will be required to keep the 10 or more units in one room going than would be needed to keep the one room going on a single batch.
The company is clearly trying to do it this way, I believe only a decision that the FlaskWorks unit can't do the job would change that. It may be taking longer than the company thought to qualify the FlaskWorks unit, but when you're working with the regulators, what doesn't take longer than you think it will?
Gary
Gary
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