Punit's reply set the stage. I knew they couldn't plan partnership announcement and 1st patient enrolled on the same day. No company could time that. He did say 1st enrollment Jan. is possible. That leaves us with a Partnership announcement first and the trial design (protocol, # of patients, etc.) in the same p.r.- . .. ..forget my earlier post, Oncs working on the 'fine print' with PD-1 supplier.
the (speculative) weasl.
i just listened to the call - Punit would make a great poker player : ) , the guessing is still front and center.
..ever the optimist = currently talking to the 3 PD-1 players, the highest bid wins(?)
company plans on showing ALL their cards this Q. - your post 'oncs vs isrg' .....should be obvious to everyone you are a savvy investor. - gltu
Last March Oncs announced the 'expansion trial' , up to 21 patients ......'to evaluate an increased dosing frequency in an expansion of it's ongoing ph II melanoma trial'
Results from this 21 patient trial have not been released. From a common sense standpoint, Oncs must have the results in hand....otherwise why start the ph IIB ? The increased dosing schedule could show a much higher response (efficacy) than the original 30 patient trial.
The best case scenario - increased efficiency, the data secures a PD-1 partner, the trial protocol is set .. . and Merck funds the new ph II ........and we get cash up front......and we get large percentage of royalties ....and .... .share price busts through $1 .. . ...
it's called going out on a limb. . . . . . . . . . . . . .
1) trial begins without partnership
2) p.r. announcing 1st patient enrolled (start of ph2B) will not name supplier of PD-1.
the (village idiot?) weasl . . .. .. .answers soon enough.
- " the benefit was just barely statistically signicant with a P value of 0.049 "
- " Roche's AURELIA study is much larger and the data more reliable. Oxigene's data are derived from a small subset of 27 platinum-resistant patients. Given the small size of the phase II, I suspect the fosbretabulin results will regress further when phase III results are eventually reported."
"results will regress further when phase III results are ....reported."
A ph III using all OC patients is a fail - This is why the stock is selling down. Investors who tell themselves "market manipulation', "shorts are holding this down".....Good luck.
Approval is at least 3 yrs away, if at all. Looking closely at the ph II results, this is not a good investment. Not anymore......anything over $2 I sell......took a chance on readout .. . ..glta.
- post-hoc subgroup analysis- ...can't believe GOG didn't design trial with 'pre-specified subgroup' ....Oxgn should know better. .....They never realized there could be a difference in response ?...geeze
In the design and analysis of experiments, post-hoc analysis (from Latin post hoc, "after this") consists of looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely something will be found . .....Wiki.
- Subgroup analysis of GOG1862 Study Showed benefit . . . . . .
Oxgn has a headline at the top of the p.r. that investors run from, big money and retail. The term 'subgroup' is associated with 'data mining'.....used by small bio's looking to bolster the final data readout. The p value .049, for all patients just got under the stat sig requirement of .05 - Increasing the 'N' in a ph III will lower the final 'P' value. Wall street is well aware of that. Espr announced p= 0.001 in their ph II, stock doubled.
In a post-hoc subgroup analysis, data showed that patients who were platinum-resistant also had a statistically significant improvement in PFS with the combination. Among these 27 patients, median PFS was 6.7 months for those on bevacizumab and fosbretabulin compared to 3.4 months for those receiving bevacizumab alone (p=0.01
Oxgn must design a ph III using this subgroup in their primary endpoint. P=0.01 will not fail in the larger trial. Will they ? They better. Large pharma won't like the idea. They are greedy for $$$. Getting Z approved for 25% of the OC patient population .....BP won't like it , I don't care, too bad. Enrolling all ovarian patients is fine, the benefit of Z should not be withheld based on platinum status.
ps- the potential revenue and current market cap [45M] .., I have never seen such a discrepancy in bio.
for the first time could kei. be right ? "imo, this sunday's presentation is not a major catalyst"
that in itself is worthy of a pr ... .. . . [hey kei. , just kiddin]
if you guys don't mind.....a third possibility - (the ceo at the time of pr..... now gone)
Maybe,,,,Oxgn was told of the stat sig 2 sided .10 , and in there infinitesimal wisdom, got real stupid. The whole bio investing world looks for the 1 sided .05 as the stat sig standard.
Did Oxgn decide to 'dumb down' the .10 result, putting .05 in their p.r ...... ? The company should responded to the SA article.
A second indication (MCC) that responds to EP/IL-12 - this could be viewed as confirmation the Oncs EP process is valid for more than only MEL. To be honest, I'm anxious, MCC results are important..... I'm guessing MCC data is one of the 5 milestones. (?)
imho, asking for BTD with data from 29 patients ......the FDA would just laugh. Oncs intent to use PD-1 with IL-12,,,,,,,,,the final data from the P2B........that might be worth a shot on goal. GL
"why isn't the PPS skyrocketing" ......what is called exciting by Oncs, could be a big blah to investors with $$$. Wall street will decide if the data is worthwhile. The ph2b trial will begin without a Partnership .... . . .
26th annual European Cancer Conference (ECCO) Nov. 18-21st Barcelona, Spain. abstracts, etc. Would of been nice to see Oncs presenting.
Display Abstract - P134
Relationship between programmed cell death ligand 1 (PD-1) expression and clinical outcome in patients (pts) with melanoma (MEL) treated with pembrolizumab (pembro; MK-3475)
A. Daud, O. Hamid, C. Robert, FS.Hodi , . .. . .. .. .
70k @.67 ..will sell all , too many shares, FLOAT 230M ,the 1 for 10 r/s nxt summer will help.
Fmi, $25 - float of 18M ....(buyout in 15' ?)
Blue, $42 - 24M
Espr, $30 - 6M, #$%$? nice ! (at .70 Oncs has same market cap, Oncs float caps upside.
Aeri, $25 - 13M
The valuation of all 4 is high, up 25-35% in two weeks. Pullback in Jan ? Buy.
Oxgn, $2.40 - 17M - My stock tip of the day : ) _____ With a market cap of $50M and a couple of important catalyst this month [fda Roche decision] combined with the low float ......Bio's. No guarantee.