The terms set down by FDA are pretty reasonable. But that doesn't mean they will be timely. Setting up 5 centres with at least 3 in US will be time consuming, although you would think that the time to recruit will be shorter than it was in Australia.
Then, after the data is collected and analysed there will be the time required to respond to FDA responses.
I can't see the process being completed in under 18 months from now.
While that might partly explain the sp it doesn;t explain it all. Normally this sort of news would result in a rerating as the technology is in front of FDA now and the terms for trials established. And those terms aren't actually too bad. This is quite weird. Unless the company has really p@@@ed off all brokers and fund managers who wanted in over the years? It would be interesting to know what's going on here with the sp.
As an aside, I wonder if they have enough now for TGA approval?
EMV Price at posting:
$1.93 Sentiment: Hold Disclosure: Held
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