Senti,
I certainly feel the same but I have a feeling in my gut that we have a Catch 22 situation in which the Journal publisher wants to wait for an event to happen that's totally out of the control of either the company or the clinician. I.E. it would be something in the hands of one or more of the regulators.
If I'm right, there is no telling how long the regulators may take to do what the Journal is waiting for. Meanwhile, all the efforts of the company continue to advance. Perhaps most importantly they're going for approval of their manufacturing capability, I believe all four regulators require that before they'll approve a product.
Years ago I remember a drug which was found not to have sufficient shelf life, I believe the spec called for 3 years and it was found to only be good for 2. The drug had the potential of saving the lives of babies with a rare condition, I would have thought the FDA could issue some sort of conditional approval, but they didn't. It took years before they resolved the stability problem, no telling how many babies died, but the FDA stuck to its guns. I always am saddened when I hear of such decisions on their part when I believe a reasonable compromise could have been worked out.
I believe that years ago when the German's insisted that all patients get the vaccine up front a strong case could have been made for early approval of the vaccine. At that time I don't know how advanced FlaskWorks was, and I suspect that all production would have required cleanrooms, so the timing wouldn't be ideal. If we never heard of FlaskWorks I suppose that's where we'd be. Clearly with development of FlaskWorks units it is the right way to go, so its adoption establishes the critical path to approval.
I know it may sound crazy, but if an issue from one or more regulator was delaying a Journal, but it was of no concern to other regulators, a regulatory approval could be possible before the Journal was out. I'm not suggesting this is the case, just that it could be a possibility. It's my belief that the U.K. will approve the production facility before the end of this year so an application for approval could also be considered during the same time frame. I'm of the belief that an approval is possible this year, perhaps as early as late October.
Gary
