I suppose the key modifier is the phrase “post approval”.
However remember the ann from Oct last year which said that illumet was (at that point) “now available commercially”. So this is an update that seems to imply that this is No Joke. They are not giving the stuff away.
One thing we don’t know is what costs of manufacture are so that will be an interesting thing to,look out for in future quarterlies.
So let’s look at where things stand.
Firstly they’ve sorted out a production pipeline for 20k units per year. Getting your supply chain right is a big deal and for me a very important positive, having been invested previously with companies where timelines for this blew out.
Secondly they’ve made the point that the NDA is being submitted after careful consultation with the FDA.
I would hope that means the FDA is happy with the 250 person EU trial database and that there aren’t funny issues with that information (a la the older non-placeboed FTT trial)
Thirdly the naive statistic is that 80% of NDAs get up. So as far as playing the odds you’d have to say worth a punt. And this is only one of their products.
They’ve not been an HC ramper’s darling which is also a good thing for me.
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