My boat is piled high as well.
I think it is very likely the adcom recommendation is positive. What the stock price does in the short term is anyone's guess. On one hand, it might not move much because Baxter is a few years from having enough Ig product to expand the SC market. On the other hand, FDA approval would open the door for US expansion of the platform. Remember that Roche/Genetech hasn't even mentioned making Herceptin and Rituxin SC in the US. That will happen one of these days. Perhaps the Hyqvia crack will allow the door to open more soon.
The most important news over the next year will come from Roche and the rate of rollout of MabThere and Herceptin SC. If it is brisk, expect more partnerships to be announced. Of course, you will never know when.
Then keep your fingers crossed we have progress on the insulin and pegulated fronts. There is lots here to make this an excellent long term play. I'm still aiming for $40 in 4 years. I have no idea what twists and turns we will take on the way there.
used for RA as well
Thanks, Sudn. I just don't have any feel for either the regulatory or the commercial risk.
Funny. My first shares were under 8 last summer. Kept buying up to 13 and mostly held thru the highs. Bought more on the way down from 15 to 7 and, you are correct, poked back into the black in the 9s and now holding more HALO than ever. I feel better here than when we were at 15. GLTU
You may be right as you have often been in the past. Because it isn't my style doesn't mean it won't do well.
Good luck with it.
Radio City 1980 - some of the acoustic shows! Good stuff. Enjoy. Should be extra sweet today if you owned some HALO.
pentech50 took my post out of context. It was in response to another's link to a large study that Roche is conducting to expand the label to home use. It is one of half a dozen new and ongoing studies with SC Herceptin to expand the label. Roche is clearly geared up to grow SC Herceptin's use and a current recommendation (that I am not even sure is universal) to observe pts two hours post therapy is something they must feel can be overcome, or they wouldn't likely be investing so much into these trials.
2500 patients, 477 study locations in 60 countries
A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer)
This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hoffmann-La Roche
Information provided by (Responsible Party):
First received: March 22, 2012
Last updated: May 12, 2014
Last verified: May 2014
At your suggestion, starting to read about this. I overlooked this in the past because I don't manage post op pain and don't generally invest in devices. What is the thought about diversion? What prevents the patient who doesn't need that next dose from giving it to their boyfriend? Thanks
Thanks for the link, fezz. This is news to me and I appreciate it.
Regarding your speculation about MS risk and clotting risk and use of SC product: decrease your anxiety about MS, it is a non-issue and, unfortunately, all the experience in the world with SC won't speak to the risk of thromboembolic events with IV. They are just not related. Only time will tell what needs to be done to continue PEG development.
#$%$ shareholders they would have had to file a 13D with the SEC within 10 days of buying or selling HALO stock. They haven't done so, so I think we can conclude their ownership hasn't changed. They should be filing their 13F this week to show holdings as of 3/31/14. Of course, the PEG hold happened in early April.
I am not a securities guy so I can't speak to SEC reporting rules like I can to medical stuff. (I am a doc and cringe when fezz interprets some of his online medical research) I am open to corrections from anyone who knows this SEC stuff better than me.
Torely and company is one reason I'm still here. She has her recent secondary with plenty of cash and now she has business to attend to. We don't need her trying to BS shareholders. You either hang tight or sell to the big boys. She doesn't care.
Not sure they have a date of planned analysis.
"ASCO Late-Breaking Abstracts Policy allows for the submission of Late-Breaking Abstracts only for randomized phase II and phase III trials for which no preliminary data are available at the time of the abstract submission deadline (February 4, 2014), but for which a preplanned analysis of the primary endpoint is scheduled after that date but before April 1, 2014 (deadline for the final, updated Late-Breaking Abstract). During abstract submission, you will be required to provide the date of planned analysis. The policy is not a mechanism to allow for updated data to be submitted later when preliminary data are available by the abstract submission deadline."
Even if the neurologist knew the CVA pt was on PEG, how would he make the attribution?
Wasn't the deadline for abstracts in February? At any rate, it was right about the time she was asked about it. Perhaps the data wasn't mature. I don't believe it has anything to do with the halt since the DMC didn't act until April and it would not have been possible to know about the halt in February.
While I think there is something very wrong with the tale about the tweeter's friend's dad's neurologist, I do believe that you, fezz, are truthful. You wear your emotions on your sleeve. Except for the sudden and somewhat understandable 180 you did earlier this month, you have been consistent.
The reason I believe "thromboembolic" probably refers to VTEs is simple odds and the generally accepted inference of the word. It is possible your two CVAs and a number of DVTs have the DMC wanting to know if they are somehow connected. But even in the most profound hypercoagulable states, VTEs will happen at a far greater frequency than arterial events. It makes less sense to imagine the problem is just embolic CVAs. If it were, it would be frightening, but also very weird.
So, there has been an imbalance in the number of clotting events. They stop the trial early to sort it out. They will look at each participant and the circumstances of any clot, look for predisposing factors such as A fib, VSD, carotid disease, valvular disease, tumor bulk, liver disease, ascites, CHF, nutritional state..., review any lab work that might give clues as to why a clot happened, including looking for known genetic causes of clot susceptibility and decide how to proceed. This is the time to make such an intervention, early in Ph2. OK, it slows PEG down a bit. But I'd rather this happen now than in Ph3.
I think we can all agree that we don't know what is meant by thromboembolic in the context of this halt.
Fezz clearly believes the reason for the halt is dire and he is way out on a limb trying to convince us the word means stroke. To support his theory he has found mention of a single stroke on a poster and surmised that CVA was the tip of an iceberg. To bolster his theory, he has slowed his typing down to explain that a tweeter's "friend's dad died of a CVA after joking the peg ph2 trial in October." And Fezz even has third hand information that the treating neurologist attributes the CVA to PEG! Really? How would he know? There isn't a body of knowledge that associates this new experimental drug with strokes. I doubt he saw a big 'P' on the MRI. I might tell a stroke patient who has intermittent A fib his arrhythmia is the likely cause because there is a century of data showing a correlation but I would NEVER be so irresponsible to attribute a CVA to a study drug before the study is finished. It's unthinkable.
Fezz is way out on a limb and climbing higher on the branches of studies he clearly doesn't understand. Don't mistake the ability to research, cut, and paste with knowledge. It is much more likely there has been a statistical imbalance between cohorts in the rates of the more common VTEs and, after careful review of all the data, HALO and SWOG will restart the studies with or without prophylaxis. Of course, we don't know. But there is no logic in fezz's theory.
Only loosely following the discussion anymore. Fezz, bull or bear, has always been difficult to follow with his/her style of writing. If you are new to the stock, find any link fezz points you to as they are relevant (such as the ASCO and ESMO PEG posters from last year) but be very wary of his interpretations. That said, some points:
The CVA death in the PEG cohort can not be attributed to PEG at this time. The vast majority of these are embolic and come from the heart in A fib or the carotids. There was one incidence of A fib in the PEG cohort but is not clear how that relates either. The fact is, these sorts of things are very common in such a sick population.
If the CVA were hemorrhagic, it would not seem to be part of the current "thromboembolic" concern.
The story of some patient's family sending a note to fezz that their loved one died from a stroke and the neurologist attributed the CVA to PEG is so wrong on so many levels I don't know where to start. But, as a doc who cares for people in trials, I can tell you no doctor would be able to know that nor would they say such a thing. The vast majority of Thromboembolic events are DVTs and PEs and they don't really have anything to do with CVAs so I think that finding a CVA death on the poster is mindless fear mongering. Alnd all can be managed medically.