I had a call with the company today. It was a good call in the...

I had a call with the company today. It was a good call in the sense i feel better informed of the current situation, but there's also a renewed frustration...the reminder we're in a mess which is the result of bureaucracy gone nuts. A lot of it seems to be plain bad luck.

From what I heard today, there have been definite hiccups along the way with BSI, but such is the dysfunction in Europe that I can't I help thinking/speculating we could be in a different situation if a different notified body had been engaged, just because it was a different day of hte week with different people involved or any other random reason. Nothing to be really gained from that exercise, but it paints the picture of European regulatory affairs I got.

It is the EMA, however, that are the core problem. In short, the EMA is not following its own rules and processes. It seems to be an arbitrary thing, with other companies getting through on other occasions (I seem to recall someone posting on that at some point). And they are being non-responsive to the communications of the company. A QC has been engaged who specialises in these situations (it isn't overly comforting that this happens enough that there's a specialising QC!), and who has taken on the EMA previously and won (ok, so that's good). There's a two-prong strategy in play: (a) continue to try and get the EMA to see reason and get on with doing their job (!!!); (b) prepare for an application for judgement in court. For (b), you have to be able to demonstrate that you have exhausted all avenues to resolve with the EMA, or the judge will just tell you to go away and try harder. So the company is collecting evidence for this purpose, and unfortunately that takes time... If (a) fails and we head down the road of (b), the best case scenario is EMA settle out of Court (no waiting for a time of hearing, no time wasted making arguments and waiting for a judgement). We seem to have a good case, but it's the law so who knows, and I'm no lawyer anyway. Obviously this admin process we're in of building a case can't go on indefinitely - yes I asked the question of "when do we pull the pin" but no answer available on an individual basis, the Board will notify ASX in due course. Also obviously, we'd be pushing for expedited manufacturing review once the EMA are back on track, but there are no guarantees there.

So we're in the waiting game for a while yet, in my humble opinion.

In terms of other jurisdictions, both Australia and Canada have reciprocal arrangements with Europe, if we tried to get something in play here, we'd just get put on the backburner pending a decision from the EMA. Maybe I haven't been paying attention, but I didn't realise that.

Aside from the EMA issue, the other area of focus is prep for the FDA/IND for US trials. All other activities have been frozen to conserve cash.

Lastly, on the competitor front - have these delays put at risk our competitive advantage? None yet have come to market with the same proposition, that is, same degree of effectiveness and the significant reduction in costs. That's all good, but getting into the marketplace asap is what is needed to secure the future of the company. Watch and wait ... and hope for a bureaucratic breakthrough.

Some/most/all of this may have been known to you, but hope it's been of help to some. Also hope I've been able to explain clearly and accurately. All the usual DYOR caveats apply of course. Others have said it, and I'll reiterate, I got a response to my request for info lodged on the company website in under 24 hours. It's the best way to get an update.

Cheers.