Yes. In fact, the delay has been helpful.
If Oncosil had been approved last year, but not yet started distribution and actual selling, it would have been in the group subject to delays and costs in transferring their CE mark.
So, the real news is that the FDA has opened the door to a pivotal trial. The question is: will the company partner for the trial or try it themselves?
Most Australian biotech/medtech companies would attempt to capital raise and do it themselves, giving the executives several years of wages while they wait for a binary outcome, which is statistically likely to be negative.
I hope that Oncosil will partner prior to the trial.
This, for a single product small company, is the best outcome for everyone, especially the shareholders. Partnering validates the product, brings forward revenue, and derisks the next phase. Apart from Cochlear, single product medtech/biotechs in Australia have no hope other than partnering. Sirtex proved that. I'm not saying that's the way it should be, just that's the way it is. Not enough skills, capital, executive nous, too far from markets, tendency to shonkiness, etc. etc.
So, I'm waiting for the partnering announcement, not the CE Mark.
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