Maybe someone else has noted this, but the press release specifically states the FDA informed the company on 19 April. However, the news was released after the market closed on 20 April.
That means anyone who bought shares today did so in what amounts to a false market.
I think it's technically legal to delay announcing key business news by 3 days but I'm struggling to think of another example where a company with a critical pending NDA or 510k who delayed informing a rejection by one business day.
It also defies belief that - despite sitting on it for a whole day - they were apparently unable to give a brief summary of the FDA's key points in its rejection.
My guess is the FDA response is absolutely brutal and the company will probably have to do substantial additional clinical work before submitting it through the alternate PMA pathway.
I think a new trial (taking that to be a full Phase III trial) is a severe issue here:
1) They could attempt to use the just started EU Phase III trial (it was a bit of a tell that half the sites for this EU trial are in the US, despite this trial being apparently only for the EU authorities). More likely, the FDA will seek amendments on end-points and may want a bigger trial - adding time and cost.
2) Even if somehow the FDA wants no amendments, ClinicalTrials shows the EU Phase III isn't due to report until late 2018. That means, at the earliest, the US launch is now deferred to H1 2020. The company has nowhere near enough cash to last that long and a substantive interim equity raise will be essential.
3) The company has said they would only proceed with the NET indication if this approval came through. According to the recent 10-K, The NET market is 50% bigger than the acromegaly market. This larger indication is now dead.
4) I think the Servier monthly injection drug goes off patent in 2017. Therefore, the acromegaly market should be much more genericised by 2020 (making a new premium-priced launch much more difficult)
Given the now locked-in cash burn until 2020, I don't think you can rely at all on the book value acting as a floor for the share price next week (the market may move down initially to book value on the Monday opening, if so I'd grab it and sell). Bear in mind there are also nearly 2M warrants at $0.09 so the 'real' share count is about 10% bigger than officially shown.
Having said all that, you could well be right and I'm just being too pessimistic - perhaps Monday's PR will be relatively mild (say the FDA just wants a small additional PK-type trial).
As you've no doubt guessed, i was short here. However, I've been long into NDA's multiple time and been bitterly disappointed several times. My deep learning from those CRL's: have a beer or a glass of wine this evening. No one was hurt here & you'll win this back sooner or later.
The fact they are deferring the CRL explanation until Monday morning (which I've never seen before!) tells me it's most likely a severe rejection (e.g. the first Phase III trial has been completely rejected and/or the FDA have identified safety concerns).
I think was has happened here is as soon as they were informed by the FDA of the outcome (i.e. just after 5PM EST) they halted the stock. This was to prevent any leaks of the outcome being used to illegally profit from the news.
If that assumption is correct, the company has been spending the last hour thinking about the press release they must issue.
I have to say if the news was good, the press release should have come by now as they surely have a pre-prepared version waiting to go that would require very little amendment..
However, if the news was bad, having a pre-prepared version isn't much help. In particular, they will need to give a broad outline of why the FDA rejected the NDA - e.g. a drug manufacturing problem would be a 'minor' fail and likely fixable within a few months at low cost but the FDA being unhappy with the first Phase III trial woudl be a lethal blow.
The longer this goes on, then frankly the more likely an FDA rejection has happened here.