There is no question that the FDA acceptance today is a major piece of very positive news that significantly de-risks the KERX investment. With positive Phase 3 data and an SPA in place, the only pre-approval regulatory risk that remained was that KERX, which has never filed an NDA before, would somehow fail to satisfy the demanding regulatory requirements for acceptance. A very high percentage of NDA's are NOT accepted in the initial filing; and KERX management made a wise decision to spend top dollar to get the best regulatory consultants to assist in their filing process. Hats off to Bentsur and team! So what do we have to look forward to over the next few weeks? (i) We should get a PDUFA date with the 74 day letter which KERX will receive in the next 13 days -- PDUFA could be as soon as 6/8/14 ; (ii) the Phase 2 trial should complete in the next 3 weeks, and since the trial is placebo controlled, it should not take long for a top line read out ;(iii) we will have CKD data by early Nov. and given what we know from JT -Torri's NDA filing, we have every reason to be optimistic ; (iv) we can expect to get Japan CKD data any day in a US publication; (v) at some point KERX should provide us with an update on the compassionate use extension trial; (vi) KERX will have posters and presentations on Zerenex at ASN; (vii) we can expect the EMA filing before year end; (viii)Japanese approval for NDA filings typically takes 11- 14 months , so we could have an approved drug between December and mid Q-1 -- with the corresponding milestone payment and initiation of a steady stream of double digit royalties; (ix) we may see more key hires for negotiating leverage and to position KERX to commercialize; and of course,(x) we could have a buyer step up at any time. Today was the risk-off trade. They threw out babies and bathwater. It may not be over yet, but I am betting on the baby.
Thanks ockerfan, it's nice to see you still here. Always enjoy reading your post. I had to add a little bit to my position today, what a gift it was to get a drop like this after great news and have some dry powder to take advantage of it. Only used 50% of the powder today and waiting to see which way it's going to go before I use the other 50% set aside for this holding. Thanks again for all your info on Zerenex and what you provided during Perifosine also........GL