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GERN:
I find it somewhat humorous that people doesn't trust Tefferi when he says that they got CRs. The man, together with all other KOL in MF recently redefined the criteria.
GERN:
Well I'm not much into these data so I wish everyone good luck. I haven't owned any GERN for months so I haven't benefitted at all from this run.
As for your personal hematologist, it seems like he or she needs to update themselves on the Jakafi data.
GERN:
1) My point is that AF is picking up on a valid and important point. They aren't reporting an (the?!) important clinical parameter in this disease. And in most biotech, but especially GERN, unmentioned important parameters that they leave out are ones that don't look very good.
GERN:
Actually, I don't fault the company on this one. AF jumped to a headline before reading the abstract carefully, and I pointed this out to him on twitter early in the morning. He has since amended his first article.
The abstract is pretty clear that they are reporting CRs and PRs for specific criteria, rather than overall CRs and PRs.
ARIA:
I find it very interesting that the statement about the eyes was essentially highlighted by the FDA....without regard to their obvious breach in common sense. Odd.
ARIA:
Your observation would seem to rule out the kind of genetic link that was posited in #msg-92847434 (which I didn’t buy anyhow).
ARIA:
Sometimes drug treatment is just as much art as science, and experience can make a meaningful difference around the margins.
So i'm curious why a couple of the large volume places that i've seen presentations from haven't had the negative experience that the larger dataset reveals. As jq said it's not wise to extrapolate from one or two centers, but sometimes a competent center or two can bring their experience to play and develop novel / optimal use strategies.
There are 68 centers in PACE trial listed, each site probably enrolled very few patients, can't use frequency from a few centers to judge safety profile.
ARIA:
We're not going to get such data, but I'd be interested to see how the SAEs break down by centers.
Through the various places I'm in touch with, these events aren't taking place at any notable frequency.
Gotcha...
Lots of people are pointing to dosing and the AEs, but that's obviously irrelevant if the exon skipping is being promoted. IF these patients in the drisa trial had exon skipping and dystrophin production, then that's bad news for SRPT.
I'll be interested to see dystrophin data from this trial. The dystrophin data released by SRPT was spotty and unimpressive, so a more comprehensive report from this drisa trial will be nice to see.
This is why Prosensa could not give such a high dose like Sarepta could with the patients.
Shkreli:
Apparently a 2 page link-bait article with a few bolded passages is the fast track to being a biotech CEO.
Thanks for the pointer. I don't know whether to laugh or cry.
OT:
What's the big deal with this Shkreli guy anyways? AF is blowing up on twitter about this thing as if Shkreli just jumped the shark, but what has Shkreli previously done that's so great?
Ah yes, I forgot it was PCI based flash.
Well, perhaps eventually someone will make external enclosures for those two. But in the mean time, you're very correct that SuperDuper won't provide the swapping capability that I like,
I should have mentioned one other thing. The external back-up disks that I use are 2.5 inch laptop hard drives that I put into a reusable external enclosure. That way, they can be used as an external USB backup disk and, if necessary, the hard drives in them can be swapped out anytime. The bonus here is that if you use SuperDuper and your laptop hard drive fails, then you can simply take the back up hard drive out of the enclosure, pop it into your laptop (deceptively easy) and continue as if nothing happened*.
As for restoring through Time Machine, you're very correct in that you can use the program to do so. However, if your laptop hard drive fails and you want to restore through Time Machine, then you need to buy another drive, put it into the computer and then use the external Time Machine drive to restore. With SuperDuper! you can just swap the backup drive directly into the computer and you'll be back posting on iHub within 5 minutes (!).
And yes, SuperDuper and Time Machine can be used together. Although both are forms of backup, they have slightly unique niches.
Regarding my comment about use on laptops, my understanding is that changing the hard drive on an iMac is relatively cumbersome and not something people look forward to. In that respect, the convenience of having SuperDuper diminishes since you'll probably have to take it to an Apple Store to do the swap. In contrast, it's very easy on laptops as long as you have a 10 dollar set of screwdrivers. I suspect the new Mac Pro will also have easily swappable drives.
* Depending on when you made your last SuperDuper clone, some files may be out of date. Time Machine or another service like Backblaze can remedy that situation.
In addition to Time Machine, I would strongly recommend picking up a copy of SuperDuper!
This program allows you to make a clone of your hard drive in an external hard drive so that *if* something happens, you can simply swap the drives out and continue as if nothing happened. This solution works best for laptops.
I've never really been able to get into Time Machine. There was something cumbersome about it, at least to me. I use Backblaze for that capacity, and it does allow you to fetch older versions of files although that's never been something that I've used.
ARQL:
Not entirely accurate
ARQL:
Also, how did they come up with the conclusion to reduce to 120 mg?
ESPR:
What do you think of ESPR at these levels.
ARQL:
But, I have to lower my outlook on chances of success for P3 HCC trial now.
ONXX / AMGN:
I'm still a bit surprised that there isn't a CVR along with this deal. I understand ONXX's reticence to ask for one, but AMGN now has a lot riding on carfilzomib and it's 3 in-progress trials. I think it's a good drug, and the royalties from the other programs should ease some nerves, but still...
It appears that AMGN is desperate to buy something. AMGN could easily buy ONXX for under $100.
What about discontinuing the head MRIs? Could that indicate the drug is demonstrating little or no effect on brain mets?
Chugai / ALK:
I read on a patient message board today that Chugai was amending their trial soon to increase the dose for healthy patients from 600 mg twice a day to 900 mg twice daily.
They are also reportedly stretching the scans out from every 6 weeks to 9 and are discontinuing the every 6 weeks head MRI.
Would you think amgen would be better off buying back another $10b of it's stock or buying Onxx?
Off the top of my head Amgen has bought back somewhere in the area of $20b buying back its own equities over the last 5 to 6 years and I'm not sure it paid off.
ONXX:
the second is the savings that can be wrung out of the combined company in both SG&A and R&D (ONXX is not exactly lean)
and the third is the projections on Nexxar, Kyprolis and their royalty from the PFE drug.
INCY is another story - that could be a good target for someone who understands what they are doing.
The primary question for me is how sustainable is that attention?
Is this going to fade quickly, or rather, are we at the beginning of a sustained increase in pps related to an ongoing M&A bidding cycle?
You still hold your Ariad position?
Re: ONXX
I hope this story is true but I have my doubts.
OT:
1. I do have physical gold. I bought it a few years ago at ~$800. I do not trade gold. So, I feel good. Regardless of bogus statistics, there is a limit to how much paper money and paper gold Central Banks can print can print.
OT:
DMSO is a liquid that you can dissolve a wide variety of compounds in. So when you're testing certain compounds, they'll have low solubility in water (or a similar aqueous solution) so you'll dissolve them in DMSO prior to their addition to the cell media.
Since DMSO is an organic, you use it as the control just to make sure that the effect you're seeing is from the drug, not the organic solvent that you used to dissolve the drug in.
ARRY:
ARRY has talked for some time about their ability to select an indication for MEK162 and run a pivotal trial in that indication. I assume that ARRY gets greater economics in this selected indication than they do from the other trials that NVS is running.
ARRY:
Thanks for the pointer. Data look ok to me (if we disregard the drug switch), but as you say I would have liked that additional sweetener for the phase 3 to tilt the scales towards the MEK inhibitor. And perhaps an SPA would have been nice, although those seem to be falling a little out of favour lately.
And please somebody tell me they didn't spend time and money making that uterus / fallopian tube-looking tulip art for the MILO trial...
Edit: And as you say, i really really don't understand how you move into a phase 3 with one drug based on clinical data accrued using another drug. Even if they target the same signaling pathway.
ARRY:
I honestly don't understand its decision process. As if it doesn't have enough on its plate already with 520 and 614 which are supposed to be in pivotal trials soon, it has to run a ph3 trial based on data not from MEK162, rather from Selumetinib, without selection of RAS/RAF marker.
Ok, AMGN demonstrated non-inferiority, but I can’t see any commercial consequence from this study.
ARRY:
One point of confusion for me that perhaps you can clear up.
Is ARRY running this one on its own, or is this one that NVS sanctioned that ARRY is leading? Because the other two trials it says NVS is running them.
Distinction without a difference, or is this ARRY trying to assert some autonomy?
Vin:
Check the other paper I linked in the last post.
The results are in regarding the TOV-112D cell line.
Edit:
, What is amazing to me is that you were hypercritical when the issue of fraud in science came up, but it appears you aren't being critical enough now. You were accurately complaining about truncating Westerns, and they did that. They only used one primer pair to look at mRNA, which sure isn't very rigorous. I am trying to get at is the precision and accuracy of the analysis of the TOV-112 cell line, but you seem to not be as concerned about rigor as I am. What gives? Is it because you are close to this research area?
ARQL:
You sound like a pretty clear ARQL bear. Is that true, notwithstanding the current valuation and quite positive Phase 2 HCC data? Nothing wrong with that and respect that but just wanted to be clear.