I agree with that completely, all I'm saying is that without the EDEN they're very limited as to how many patients they can treat. I forget exactly how many tiny cleanrooms exist at Sawston, but think it's something like 20, each cleanroom is capable of 50 batches a year, that would be 1000 patients who could get DCVax-L. If I were wrong by a factor of 5 and we had 100 cleanrooms, that's still only 5000 patients a year.
The company's relying on the EDEN approval, they're not building more tiny cleanrooms. Real revenue isn't possible until the EDEN is available. People have only guessed as to what an EDEN will cost when mass produced, most seem to believe it's in the tens of thousands of dollars, let's say they're off and it's $100K, the first paid batch it produces should more than pay for the unit. I believe if the price is right, the company can find producers that could make 1000 a month, or more. 1000 units producing 50 batches a year is 50,000 batches, it won't be long before we're producing over a million batches, though it's over a year at 1000 a month. If the demand is there for a million batches a year, I'd bet our producer could either gear up to produce more, or we could find additional producers.
I believe the real question is, how long will it take to go from treating GBM till we're treating many other cancers. I really believe that some oncologists with wealthier patients will be recommending it from when it's initially approved, and if surgery was done prior to that they'll have cryogenically preserved the tumor. If I'm right, the anecdotal evidence will very shortly force insurance to pay for other cancers, that's why we need tens of thousands of EDEN units shortly after we gain approvals internationally.
This doesn't happen instantly, if we don't actually file for approvals until the EDEN is approved, we're speaking of at least 8 months beyond that point. On the other hand, if we felt certain the EDEN would be approved in 3 or even 4 months, we could file and it would be at least that long before the commercial production facility would have to be ready for inspection. We don't need tens of thousands of EDEN's in the production facility, a few dozen would probably get the job done as long as it was clear that more could be added.
I'm still of the belief that we'll contract with CRL and use the Memphis facility for US production, but Sawston is also preparing some large cleanrooms to accommodate multiple EDEN units once they're approved. They may supply all of Europe once approvals are obtained. As always, this is JMHO.
Gary
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