The benefit seen in the poor prognosis group of SYNERGY was in first line treatment, AFFINITY is designed to treat as second line treatment. Must assume they are analyzing the poor prognosis group with second line treatment as well in AFFINITY, but that is not specifically stated.
I thought the stats seemed too favorable when compared to the subgroup in SYNERGY. Critical HR of .78 seems highly probable for the same patients and protocol as in SYNERGY.
"considering Teva is out and they own Custirsen outright."
I assume ISIS owns small percentage of royalties (most likely low to mid single digits) although I have not been able to find this figure released in OGXI's 10K. If ISIS does indeed own about 5% I would not consider this as a negative since ISIS's technology is red hot and widely revered.
Since the poor prognosis group has to meet a higher bar than the ITT population, if Custirsen hits the first mark, the second mark also becomes probable.
So the way I read the trial releases leads me to believe that they may file an NDA for the poor outcomes group in 2016 (for AFFINITY), based on final stat analysis.
The amended trial design was proposed and agreed to by FDA and Euro, but I am not sure what it means specifically that they "agreed" on the amended trial design (co-primary endpoint) for the subset. I am sure that it is not included in an SPA, so it is not a guarantee that they will file an NDA if statistically significant.
Anyone have any idea? Have they discussed what they want to see in order to feel good about submitting and NDA for the co-primary endpoint group?
As in 10 times current value...this valuation is only possible assuming they meet primary endpoint for AFFINITY (after the amended trial design). Considering Teva has given all rights back on Custirsen, a $1B valuation is actually quite conservative for a bio with an approved cancer product.
Hard to deny the risk reward at these levels since it's basically trading at cash. If the amended trial somehow meets it's endpoint this will see at least a 10 fold increase considering Teva is out and they own Custirsen outright.
Investyes, a couple of different reasons. First and foremost we will know something regarding Custirsen/Affinity in December. I believe the change in Protocol ammendment with increased risks of poor outcomes will receive approval. Enspirit is right behind that.
Secondly, the Bio's have been beaten up badly with Hillary's tweet, which was unwarranted and over reacted to. Lastly, I believe the Fed is going to raise rates in December, which will provide a boost for the Bio's. I too am holding quite a bit of OXGI and I believe they will have some winners in the pipeline that will get attention. If all of this takes place, we will look back and think $2.35 was a bargain.
no I actually didn't. sitting with 50,000 shares which is enough for me to worry about :-).
just need them to hit on one of their drugs in testing. otherwise pennies in heaven.
30 million outstanding, big deal! please so thin to begin with. I like the price and will buy more tomorrow.