It's been some time ago that it seems like most of the companies in the world had a paradigm change in how they operated. Companies that normally had many months worth of the raw materials needed to make their products reduced that inventory to a few days worth, if that, as just in time became the watchword of industrial production.
It worked fine until a pandemic, and governments actions crippled it. Companies like GM now sit with tens of thousands of completed cars that all lack just one thing, a chip that hasn't come on time, and they may still not know when they'll get their delivery of them.
In many ways we're also waiting for certain things to happen. Regardless of how quickly things like Journals were issued and BLA's etc. were developed, without production capability approvals could go nowhere. The regulators simply won't approve a product, no matter how great it appears to be, until they've satisfied themselves with the facility that's going to make the commercial product and have the capacity to meet anticipated initial demands.
When I look at the photos of what appears to be the latest version of the FlaskWorks unit it appears to be a far more complex device than the first time I ever heard of FlaskWorks. I believe the basic concept is little changed, but much has been added to better automate the process and constantly monitor what's happening in each of many units that will be largely computer controlled, and will require little personal attention during the process. Looking at the photos I really have no idea of exactly what is part of the disposable cassette, and what's part of the unit itself and is just tying to a contact on the cassette, but not a part of what is discarded after each use. I believe the disposable cassette has become far more complex that it was when I first heard of it, and that may make it substantially more expensive to make, I still believe that St. Gobain's Glass will have little trouble in mass producing the finalized unit.
My point is, this is what must be done and certified prior to the first possible approval of the vaccine no matter how great the trial data was. The fact that NWBO has now requested the inspection of one such facility is very positive, it's approval opens the door to all the others that will be built and put into operation.
I believe other such facilities can be brought on line rapidly as the FlaskWorks units can be mass produced, and many of the locations they could successfully be installed at already exist and already have the other equipment needed to support their operation present and operating to make other products. Let's get Sawston approved and the others should follow in short order.
The point I'm making is that everything is coming together, but regardless of whether the trial ended months or years earlier, regardless of the time taken in developing the documents to approach the regulators, or how long it's taking to get a Journal out, nothing can be approved until the FlaskWorks units are ready to be deployed, and it seems like we're just reaching that point.
I believe it's all coming together and we could have at least our first approval, and perhaps more, this year, but it all depends on the approval of the facility at Sawston.
Gary
