I do not think that any management could secure ANCHOR. Most of the market were confident and thought that ANCHOR will be approved. It’s still not clear why FDA acted as it was, but I do not want to be “Mel Gibson”.
Do not forget that drugs basically approved based on hard outcome, however the FDA COULD (but not have to) approves drug based on surrogate endpoints, so:
ANCHOR (for zumanto also): FDA did not say it’s useless, they are just not sure it’s effective. They can do it since ANCHOR was not based on hard outcome. (I am not going into the details regarding the process, guidelines and etc., since it was discussed several times, but shortly it was unexpected and they do not have a good reason, top of that: they can do it.)
SPA: FDA could not stop R-IT. If AMRN follow the SPA (and I am sure they will) and R-IT will show the safety profile as expected and eff. will be at least 15% (I expect higher, at least 22%) I do not see any possibility for denial, since R-IT result will be a hard outcome.
negative NCE: not good, but will not effect the company daily operation (low PPS is not good for us as a shareholder, but the relation is exist as a one-way effect only: poor operational result decrease the pps, however the low pps does not effect the company operation)
uphold by OND (SPA): it’s bad and in this case I do not expect a turnover from the next 2 level, so around March 2015 they will go to court
KOWA / time / etc. - Yes, they still have time. Within a month we will know the Q2 result, but let’s work with previous figures:
- Q1 burn was 27M (9M / month) and cash 164M by 03/31. If we apply the same burn rate per quarter they have cash till end of Q3 2015 (18 months), but
- 14% reduction in OPEX is 4,5M so it additional one Q (6 x 4,5= 27,1) = till end of Q41015
- any additional script over the Q1 level is financing 2016
- the operational breakeven is at 30k scripts / week (with Q1 14 OPEX) which is doable (of course not immediately)
- R-IT interim events number will be reached 01-06 2016
- DMC meeting is scheduled quarterly and they could stop R-IT anytime if the data support it.
