Certainly, any big deal with PEG that brings $$$ to HALO with be greeted with enthusiasm by Mr Market as it would erase any doubt about PEG's future. I don't have much doubt, though. My biggest reservation to selling any rights has to do with the eventual buy-out. One attractive deal might be for European or Japanese PEG rights for cash. I would do this if it allows HALO to aggressively pursue other obvious indications. But the downside is that the partnering company can discourage other BP bidders with eventual sale. I'd be careful.
A better future might have the next development stage come from CAR-T or other immunotherapy companies offering to run trials at their own expense using PEG.
I believe another reason for the recent jump in SP is the ASCO presentation. I was surprised by this since I didn't think there would be enough new to present. That Dr H has earned an oral presentation on PFS and OOR in 202 is reason to believe the data is new, clean, and strong.
with majority converting from competitive therapies
Thanks, but I'm supposed to play the devil's advocate :-)
Yes, there are many things that could go wrong. I could write a book. But one reason to follow a message board is to be reminded of the risks. About a month ago I posted a warning about interpreting the pre-halt 202 data as though it were based on Ph3 methodology. Go look for that, if you wish to know what I am keeping the closest eye on. In it I explained why the primary problem with the 202 data presented in January has to do with selection of high HA subjects. Worries about whether PEG's effect on. NSCLC will be as robust as with PanCan don't rise very high with me. While not certain, there is enough preclinical data that suggests efficacy in other cancers. And, while you never know, I don't see any reason for increased TE risk with NSCLC. Besides, approval for the first indication is always the hardest. If we get there, we are home free.
Of course, you don't bet the farm on any one stock. But I've done very well over the years identifying a handful of biotechs to be invested in at any one time. HALO looks like another winner to me.
The deadline for abstract submittal was in Feb. It's possible they might rework some of the 202 data they presented in January but I wouldn't expect too much.
Either got very lucky, or they liked our envelope! My wife and I will travel from California to Chicago and then be walking everywhere. Can't wait.
How about you?
...now. There will be a lot of noise. The stock price will go up and down, but it should ramp slowly to that day of approval.
I believe that looking for near term catalysts in a stock like HALO is looking at this investment the wrong way. While not "day-trading," I might call it "month trading" to illustrate the similarities in trying to time relatively near term events. I don't think you can make money with that perspective. The market is too unpredictable and too efficient in the near term. The market inefficiencies we can take advantage of in biotech are usually about 1-3 years away. That is the sweet spot that is relatively protected by other investors' impatience.
So, with HALO, you should look at the future time when it becomes clear to even your grandmother this company will make a lot of money. That is the day PEG receives FDA approval. Then discount from there.
By virtue od the fact that it can uniquely improve nearly any chemo regimen in any solid tumor with high HA production, PEGPH20 is likely to eventually become a multibillion dollar drug. It will take time to reach those sales levels, of course, but that potential will easily make HALO worth 10 billion upon PEG approval. Conservatively, I believe that day is three years from today.
What happens between now and then, when the worth of your investment more than quadruples, is too unpredictable to trade. But expect any news of he SWOG study or 202 that confirms what we know about safety and efficacy to boost share price somewhat. If OS numbers on the early pre-halt cohort come out, that will give us a boost. Expect any news about the progress of the HA test to help. Any news about lung cancer enrollment or the checkpoint inhibitor HALO plans to use in the other NSCLC trial will temporarily affect share price. Any news on partnership of the insulin products will help assuage any ( minimal) fears of dilution before PEG approval. And the market will always be keeping an eye on Enhanze, Hyqvia, and Hylenex revenues. Just don't let any news on any of the above distract your focus on the prize three years from
Today's news is great news! Those of you who are disappointed by no mention of breakthru status were warned you were being set up for a fall. Get over it..
HALO was given special status by the FDA to be able to start Ph3 early and possilby use PFS as an endpoint. This reflects good data so far, trust in that data, and the importance of this treatment.
Who needs BTD?
No, I'm still in. Thanks. Have just about doubled my money there. My stake there is less than HALO but still significant. Because of it's run, ADXS is now my second largest holding. By my analysis, both companies have the real potential for doubling, tripling, or better over the next two years but. I consider HALO less risky.
who is here in HALO now because they think there will be breakthrough status this year will be very disappointed. This drop has nothing to do with that. The large shareholders who might have influenced trading today have other things on their minds, I assure you. This has NOTHING to do with breakthrough status.
Don't sweat it. Today march options expire and someone big sold 2000 March 15 calls a couple of weeks ago. That represents 200,000 shares that need to go for under 15 today. Since HFT represents many times the volume of real trading, those 200,000 shares probably represents most of the real trading today.
Take heart; the same entity bought 2000 April 16 calls at the same time so you know we are likely to be well over 16 in a month. You might consider trading around this knowledge.
In order of probability, IMO:
I am hoping they stay independent until PEG approval. Should be able to fetch 10billion by then.
When is enough enough? :-)
I've got plenty. Thanks for the tip.
I've listened to that presentation three times. I LOVE it. I am very confident in this company. I also have a very good feel for FDA decisions and, IMO, they require more than this to approve. I don't at all believe there is data manipulation. I am only pointing out room for that and the FDA has zero tolerance for this kind of ambiguity.
I suppose we'll have to agree to disagree. If you are correct that HALO gets BTS in 2015, I will toast your health and our mutual wealth.
"This data, along with the gestalt of all preclinical and clinical results, is good enough for me to invest a boatload in Halozyme, but it won't be good enough for the FDA. "
So, not only isn't it clear that the new test will replicate the old method, it appears the HA determination had been done after results had started to be known. How can you cite data from a study that threw out more subjects than was kept in without once mentioning that flaw? Since the very good results on ORR completely depend upon high HA rating, one has to ask themselves how independent these evaluations are in an open label study. I know the FDA will. Review the results you cite- on slides 66 and 67. From a post a few weeks ago on i-HUB:
To continue to play the devil's advocate (the genesis of my NdP) it wouldn't take too many non-responders on that ORR slide #66 to be classified as "HA rating not available" to make excellent results out of poor results. (The data on the next slide on PFS has similar, if lesser, problems.)
Notice that of the 74 subjects in the PAG arm, there were only 35 who had HA classification. This, despite the fact that HA classification of biopsied material is supposedly a criteria for enrollment. Also note that 12/17 High HA responded while only 9/18 Low HA responded to PAG. This might be above reproach if there weren't only 25/74 responders in the whole PAG treatment group.
Think about it; you randomize 74 subjects to PAG and 25 respond. Twenty one of those responders are in the group they have HA id on. Only four responders are in the group that, for some reason, they have no HA id on. It doesn't take much to see how data could be manipulated here. If it were truly randomized, the percentage of responders in the PAG arm without HA status id should be consistent with the cohort with HA identification. It should be about 60% (9+12 /35), not 10% (4/39).
This is why I believe the FDA will demand efficacy data in Ph3 on a cohort PROSPECTIVELY identified as High HA by a reproducible test. . They've got the test. Should be able to start the study early, we hope.
The interim look was unplanned because the interruption in the trial was unplanned. It made sense to look at the pre-interruption data on its own. It is probably strong enough, along with accumulated post-halt data, to get permission from the FDA to start a Ph3 trial before the Ph2 is finished. There even might be an agreement to use some of the Ph2 subjects toward Ph3 results, thus setting us up for possible an early Ph3 stop.
Good numbers like those your cite are not enough for breakthrough status (BTS). The study behind the numbers must have good methodology. The main problem with this Ph 2 data is that the determination of the HA status by an older method and it is retrospective. This data, along with the gestalt of all preclinical and clinical results, is good enough for me to invest a boatload in Halozyme, but it won't be good enough for the FDA.
let me explain further
I, for one, would rather nobody anticipated breakthrough status. For reasons I've gone over, it is highly unlikely in 2015. And I'd rather not worry about any downward pressure this year from the frustration of not getting it. I'd rather focus on the abundant probable milestones that will take us to the promised land in due time. OTOH, I doubt message board psychology has too much effect on share price so I probably shouldn't care.