No problem, bender. I just don't have the information that I would need to give you any advice that would be either meaningful or reasonable. And I am not a CPA or CFA, either of whom would probably be able to draw a better "bead" on your specific circumstances.
As I'm reading it the FDA doesn't need to explicitly approve enrollment for Patients 3-5, but they have set this up to be under the purview of a Data Safety Monitoring Board (DSMB) which will meet to review data. DSMBs are "expert" panels convened by each site, not by the FDA, so the lag time shouldn't be as long as it was between Patient 1 and Patient 2.
There's a DSMB in play so there will be a meeting and some admin in the mix, but they could re-open enrollment pretty much any day now.
Bender, you need to talk to a Tax professional or a Financial Adviser. I am in no position to give any advice on the issues you are facing.
We are trading on Extremely Bullish Money Flow and Relative Strength at roughly 8x our 6 Month ADV for this time of day (we've "pegged" my models which can only handle a 300% "over" rate). We are in Breakout with a calculated Target of $22.00. There are no Levels to Watch since we are too high over any calculated Support for that to be meaningful.
The Support Level I show is at $18.75. The only Resistance is that represented by the Stop for NEW Short Positions at $21.60. I would expect to see some Profit-taking as the day's trading proceeds but early indications are that we should hold the majority of gains here.
Good Luck, Congratulations and Happy Hunting.
Actually, attila, by measuring progress against the "natural history" of SCI recovery that is precisely what they are doing. That will become much more evident, I believe, in the Pivotal Study where Probable Benefit is the Primary Endpoint and it will become explicit when they pursue approval under a PMA.
No. There is no such possibility. None. At all. Period.
That is simply not the way Trials are run. "Cherry Picking" is a method of attempting to bias the results of a Trial in one direction or another. Simply put, it's cheating - you might as well have the Lead Investigator falsify the results of the Study.
Since "Probable Benefit" is the Endpoint and the Study size (even at 50 patients) would be very small there's no case to be made for sub-groups. Even under a (much larger) Trial for a PMA it would be more likely to sub-group by description of injury rather than any particular physical characteristic.
You are correct; aside from the qualification standards detailed in the Study Design there is no "hand-picking" of candidates. That would pretty much invalidate every principle of Trial Management known to the medical profession. That said, given the typical demographic of individuals who suffer this kind of injury they tend to be young, active risk-takers so it's not unlikely that most, if not all of the candidates here will be fairly similar to the first two.
Update: The Sell-Side is in "everything but the kitchen sink" mode, but personally I doubt that there's a thesis-oriented player in the bunch; just a slew of "quants" betting against the trend. There is a "stair-step" pattern emerging in the data registering higher highs and higher lows and this looks like the end-game will be capitulation.
On a side-note there was an article this morning in "24//7 Wall Street that lumped HZNP in with GILD and a couple of other solid value Healthcare stocks that UBS has as "2015 Picks" and are indicated as being Sector-Defensive - holding Value in a Sector downturn or correction - a nice appellation when the IBB is running at all-time highs and the Doom and Gloomers are coming out of the woodwork.
What a difference a few years makes. I've been a Horizon Bull for a LONG time but I never imagined that we'd get lumped in with GILD as a value pick, at least not this soon.
Patient #1 was unaware of the pre-clinical outcomes, so I am of the opinion that Patient #2 knew very little about Patient #1 (other than the fact that the procedure had been performed successfully once before) prior to granting informed consent.
Now, afterwards she clearly got herself "up to speed", and that's great. Maybe it helps with her motivation. But in terms of recruitment it's a non-issue. The FDA's position on this is very clear - you cannot claim a benefit or an effect that has not won FDA approval. That applies to manufacturers' claims, to statements made by marketing types to physicians/medical professionals and to people who are recruiting people for Trials and Studies. You simply can't do that, period.
Now, once the current Study is completed, both the Primaruy and Secondary Endpoints are fair game. That will be an entirely new ballgame. But for now, as it is in most Preliminary Studies, recruitment is going to be very heavily risk-weighted.
Except that the doctors cannot point to the success of the first two patients except to say that the procedure has been successfully performed twice with no adverse effects (assuming there are none in Patient #2, which is a pretty safe assumption at this point).
I know that it's somewhat counter-intuitive, but the FDA considers the use of interim data to convince patients to participate in a Study or Trial, regardless of how spectacular that data might be, as "coercive". Making claims like that when recruiting (beyond some very generalized description of the potential benefits) would pretty much de-rail the concept of "informed consent". It would violate professional ethics in a big way, open the Trauma Center to huge liability claims and result in barring the LI from future Studies and Trials (if it didn't cost them their license to practice).
The whole process of recruitment is geared toward identifying risks with very little emphasis on the reward side of things. At this point the doctors can claim that the risks have been mitigated by the successes thus far in terms of the safety of the procedure, but they simply can't make a concrete claim of benefit.
We are trading above our defined Support in an area of no Resistance on Bullish Money Flow and Relative Strength with Volumes running about 25-30% Above our normal 6-Month ADV for this time of day. The data is starting to reflect the formation of Support at $18.50 or thereabouts but that has not confirmed yet.
The Recommended Stop for NEW Short Positions is at $19.60. There is a Breakout Watch in play for any move ON Volume above $19.10-$19.25. We are showing strong 3-Day accumulation on my 72-hour run. The SMA pattern is Strong Bullish with the 10 Day SMA at $17.64, the 50 Day at $15.40 and the 200 Day at $13.22 with all three increasing and diverging.
The Levels to Watch are $18.40-$18.50 for Confirmation of Support and $19.25 for an imminent Breakout with Confirmation at $19.60. If the Breakout executes the calculated Target is $22.00.
Good Luck and Happy Hunting.
Think I'll pass, mo. I know how irritating it can be when people start dropping "hot stock tips" on this board - I wouldn't wish that on anyone else.
One of the reasons people come to these boards, alex, is to get an answer to a simple question; and that was a pretty simple question after all.
Here's my theory: If somebody wants the information for good and proper reason there's no reason not to share. If they are "soft bashing" then giving them a complete answer kind of brings them up short (pun intended). Either way you've put the real story out there and that never hurt anybody.
alex, you are being rather paranoid. Thought you were taking a "timeout"; sounds to me like you could really use it. I took a look at the Chief's posting history and there is nothing there to indicate that he is anything but legitimate.