The Independent Data Monitoring Committee recommended that the trial continue to the final analysis. EXEL announced this after the close yesterday, probably to allow a little time for the market to process the news and calm down before reacting. Obviously it hasn't worked.
Equally obviously, there was no leak of this data. Not that you would expect there to be, since it's a double-blind trial.
when ogxi was falling month after month down to below 7$
I don't remember a single poster touting this as being a great bargain.
Now the board is loaded with pumpers talking about the low float etc.
There was a low float at 7$ and nobody thought it was a buy on this board at that time. Too funny!
There isn't any more company news now than there was then.
It's all momentum chasers and short covering, with hedge funds that bought 200k shares at 7$ and now selling them to you.
Agreed. Also like the fact that there is little media chatter about OGXI. Price has not appreciated during last 12 months, so there is room to spurt with coming catalysts.
.Can't find another company at this market cap with such a strong pipeline. Average target price is in the 20's most analysts. Stay long with this one.
Based on your timing expectations from a month ago, seems like it's entirely possible top-line data will be released late this week / early next week. It certainly sounds reasonable, especially when considering that the late entry deadline for ASCO is April 1st.
It does seem strange though that volume hasn't drastically increased in expectation of the results...do you now think the timing will be later than end of March - early April?
BTW, realize I'm late to this board, but just wanted to give a shoutout to everyone (Summer, Avii, Bagholder, Rxeddie to name a few) for all the thoughtful contributions here. Much appreciated.
"I wonder, for OGXI, if “blinded to the details” may mean they know the trial interim HR, but not the treatment assignments. "
I would think it means that the independent statistician didn't reveal the results but just advised that the trial had not met the required stopping criteria. That leaves the possibility that there is only one person who knows how this trial is tracking. Hard to believe IMO.
OGXI: “the SYNERGY trial is continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC). …. The IDMC also remains blinded to the details of the interim efficacy data and analyses”
NWBO: “Northwest Biotherapeutics announced, in response to shareholder inquiries, that the Data Safety Monitoring Board has made an unblinded review of the safety data for the company's ongoing international Phase III GBM Trial, and has recommended that the trial continue as planned. The DSMB's review of the efficacy data is still pending. “
Hmmm, two trials with recent interims, both with odd circumstances surrounding their interim efficacy evaluations.
I wonder, for OGXI, if “blinded to the details” may mean they know the trial interim HR, but not the treatment assignments. You know, results coded “A” and “B” and they don’t know which one is control and which is treatment. An HR of .75 would be read the same as an HR of 1.33. Of course, that makes it impossible to do a meaningful futility analysis. Fleming says in his DMC book that some DSMB statisticians advocate this level of internal blinding (though not him).
The NWBO “pending” issue is obviously different, but also curious.
I think 2 points:
1) The shares are not a lot when compared to how many total shares insiders currently hold
2) The shares sold were just RSUs vesting (and done for tax purposes) - bagholderzunite probably describes it best:
"When restricted stock (or RSUs) vest, or when options are exercised, a tax liability arises, and withholding is required (usually 25% federal, and then state-by-state rules on state tax). Almost always, executives elect to have the appropriate portion of the award withheld -- the company sells it and remits the proceeds to satisfy withholding requirements. It shows up as a sale on a Form 4.
Rarely, the executive will take cash out of pocket to cover the withholding requirement. That would be a wildly bullish signal, usually. But not doing that is hardly bearish"
Avii77: It's really impressive that you were able to code a method to model clinical trials from scratch. I would highly suggest for you to take a look at R. Let me know if you need any help with getting started. It seems like you would enjoy deciphering it anyway.
“Which tools do you use to calculate these? R?”
No, I didn’t use R for this. Parmar wrote a paper in 1998 (published in Journal “Statistics in Medicine”) and provided some useful tools. I’ve implemented his methodology for my own purposes (not an easy task for someone like myself who is not a statistician). Your point is well taken in that my garage modified Parmar methodology may not have the fidelity to detect a subtle difference. My calculated 0.0494 is close enough to 0.05 that I can’t use it to refute your point about the “critical HR” not including interim spend.
I would refer you to the protocol for the Zytiga trial (available as supplemental material on the NEJM website – perhaps try goggling “nejmoa1014618_protocol”). On page 75 I hope you would agree that when they report the “efficacy boundary” at the interim and the final in terms of HR (.7975 and .8628) that .8628 takes into account the alpha spent at the interim. That .8628 would be, IMO, the “critical HR”.
So, I just tried my “tool” using the Zytiga data. Using HR=0.8628 (and the other trial design data), I obtained a p value of 0.0495. It should be 0.0462 (they scheduled one interim at 67%). I’m 0.003 off. Oh well, I guess my methodology indeed lacks the resolution to discern the alpha spend. Was worth a try though……… I’ll shut up now.
Here is the footnote directly out of the Form 4 that goes with the sale of the 4,634 shares (footnote 2):
2. Represents shares of common stock that have been sold by the issuer to satisfy the tax liability in connection with the settlement of RSUs.
No, I take that back. I think you're right. It looks like Cormack exercised options on 3/14/2014, so this sale would be consistent with his history. Sorry about that. Not trying to bash.
It appears as if OGXI CMO Cindy Jacobs also exercised options on 3/14 and sold shares on 3/17.
Wondering if the article I referenced was mistaken in calling these sales open market transactions as these are typically non-open market dispositions.
Data from Nasdaq web site concerning Cormack's recent transactions:
7-30-2012 … Option execute …34,167 shrs
8-7-2012 … Option execute … 7,000 shrs
3-12-2013 … Option execute … 4,688 shrs
3-12-2013 … Disposition (non-open market) … 2,134 shrs
8-13-2013 … Option execute … 6,562 shrs
8-13-2013 … Disposition (non-open market) … 2,951 shrs
It's not showing any selling in the latter half of 2012 despite two option execute orders. Perhaps he did pay the taxes in cash in 2012?
In 2013, each option execute transaction was followed by a non-open market dispositions. This would be consistent with your explanation. However, insofar as the nasdaq site is concerned, I don't see any open market selling by Cormack (until now) for any reason.
The fact that, in 2013, he exercised options and executed non-open market sales in March, does imply a pattern of selling at this time of year (for tax purposes). But an open-market sale by Cormack is hardly common and does raise eyebrows - hardly "nonsense."
"the company sells it and remits the proceeds to satisfy withholding requirements."
Would that be reflected on the Form 4 as an open market sale? Non-open market transactions for that purpose are common and rarely make headlines. CEOs selling shares selling stock on the open market , on the other hand (particularly with a binary event on the horizon) are noteworthy and usually make a headline or two (hence the article I referenced.)
When restricted stock (or RSUs) vest, or when options are exercised, a tax liability arises, and withholding is required (usually 25% federal, and then state-by-state rules on state tax). Almost always, executives elect to have the appropriate portion of the award withheld -- the company sells it and remits the proceeds to satisfy withholding requirements. It shows up as a sale on a Form 4.
Rarely, the executive will take cash out of pocket to cover the withholding requirement. That would be a wildly bullish signal, usually. But not doing that is hardly bearish.