Hi Mozz
The main disadvantage I can think of is a longer time to establish the channel partners and more disjointed marketing approach. The big pharma companies have channels in place that go direct to physicians already and there is a relationship with those physicians that can short-circuit some of the trust build-up time. As we know the medical profession is naturally skeptical and slow to adopt new treatments even with a wealth of evidence. Big pharma have strategies to "convince" medicos to come on board with new drugs(yes I now iPPS is not new really but in this incarnation the drug is new). The Disallowed factor cannot be dismissed either so lot's of evidence and high-profile testimonials from "truth" sources will be necessary to counter that aspect of skepticism IMHO.
The early access schemes will be critical in helping provide the wealth of evidence and although the NFL trial is not clinically significant, in the US football is somewhat of a deified profession and in the longer term those early optic wins may come in very handy for marketing.
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