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What about this S1, is that not ugly?
Expected to be ugly of course, but goes to show that all other avenues were a no go
Ok, well now board members are buying shares
Now we're just going around in circles.
Your initial post said that you thought that he was an "unbiased KOL."
I'm saying he is not and was never an unbiased KOL, he has been intimately involved in the study since day 1.
Go back to the very first entry for this study 2/2019. There is a single site recruiting, MDACC, and Naval Daver is the contact.
See the abstract from ASH 2020 that I linked earlier. Naval Daver is first author.
He has been the lead on Tusp from day 1, pre-Aptose.
It's not the first time that clinicaltrials.gov has been incomplete. Won't be the last either.
Naval Daver was the PI of the trial under Hanmi, before aptose ever got involved
https://ash.confex.com/ash/2020/webprogram/Paper143244.html
I believe that Andreef (Daver colleague at MDACC and Aptose SAB) is probably the one who brought Tusp to Aptose to begin with
At least someone is making money off anti APRIL MOA for IgAN, AUPH years behind (if they are still working on this)
High probability that all depositors will be made whole. Feds cannot allow any other result without sparking more bank runs and failures. Risk/benefit in favor of protecting depositors
Anyway, we'll find out soon, probably tomorrow
Thank you!
Also watching IKNA. J Marango's new gig
With the exception of U of Miami and MD Anderson which are offering both trials, the trial sites for Lux and Tusp are non-overlapping
May change in future as more sites are added to both studies
Rice was literally Director of the Drug Mechanism Laboratory at NCI.
He may not be the best CEO and everyone is frustrated. We've been through a lot with 253, 806, etc. I get it (I've been in since 2018). But he is not a charlatan. He follows the data (slowly and ploddingly...) On the topic of MOA of tuspetinib, I think it is fair to give him the benefit of the doubt. He has a ton more data, knowledge and experience with this specific topic than anyone on any message board.
HZNP getting acquired - good old Tim Walbert
Gg
Michael Martin bought 30K shares
Most bullish thing for this stock in a long time. Remember, he sold at 30+, maybe he thinks he can do it again, lol
Nice run from 18 to 22 these past two weeks
Remember, these two plus Michael Martin are the ones who sold at the top last year, low 30s.
What's PG supposed to say?
Because they were the architects of the failed patent strategy
$MYOV Sweet sweet redemption. I hope many of my $AUPH friends made the move to MYOV a couple months ago. I think final price tag will be north of $30. Still holding full position. https://t.co/KCkaWTo2tG
— JG (@BioLunacyJG) October 5, 2022
The tell in that sad situation was the insider sales near the top. (Wish I had paid more attention to that, major lesson learned)
Relugolix sales ramp *during COVID pandemic*
https://twitter.com/Sue_S_E_N/status/1563222011790258177?t=1pqV3RoAe6OmZN5UCNcmiA&s=19
Argument from anecdote AND faulty generalization
A logical fallacy twofer! Congratulations greggors!
Btw, AUPH is being left behind on this xbi rally. Also, KDNY is years ahead on anti-APRIL drug against IgA nephropathy.
Have a nice day!
No
https://journals.lww.com/greenjournal/Fulltext/9900/Association_Between_Menstrual_Cycle_Length_and.357.aspx
Also, mRNA vaccines do not cross the nuclear membrane and do not alter the DNA within
...but keep telling yourself whatever you want to believe
1/2 For my $AUPH friends that have been struggling lately, consider looking at $MYOV for a chance at redemption. They just had a great ER followed by an FDA approval late today. Now 3 approved indications with first two having very successful early launches. Well financed too.
— JG (@BioLunacyJG) August 6, 2022
The Q2 21 comparison quarter was a disaster. $6M? AUPH should be pulling down $60-80M per quarter by now. We're a year and a half into this.
Another option: new evidence is being provided to the USPTO by Sun which was not discussed at time of initial application (this is what is happening)
Yes.
At least that is what Jeffrey Fredman, Ryan Flax and Timothy Majors think (USPTO patent judges).
Specifically they think that Sun is reasonably likely to prevail and that is why the trial is happening. Theirs are the only opinions that count.
Maybe Aurinia can work out a settlement, maybe not. Maybe they can win the trial, maybe not. I've been here since phase II, sad to say I sold out some yesterday and the rest this morning. Risk is not worth it to me at this price.
If PG is shown the door and there is some positive development on the patent front maybe I'll buy back in.
Good luck to everyone, whatever you decide is best for you!
It seems to rest largely on the assertion of Dr. James Tumlin that the better efficacy observed in the low dose arm of the AURA LV trial as compared to the high dose arm was unexpected and non-obvious.
You can read all about it here:
https://developer.uspto.gov/ptab-web/#/search/documents?proceedingNumber=IPR2022-00617
Papp was the first author of the paper describing use of voclosporin for plaque psoriasis (back in the Isotechnika days)
In that study, patients were withdrawn from the trial if eGFR declined by 30%.
I believe that Sun is arguing that monitoring eGFR is an established method for screening for nephrotoxicity. Look, it was public knowledge even in 2008 when Papp was published. It is "prior art." Any physician competent to treat LN would be aware of this.
Further, even leaving Papp aside, they argue, it is well known that calcineurin inhibitors generally can cause nephrotoxicity.
So, the dose reductions in the patent are previously known and the patent should not be upheld.
This is my interpretation of the quote
Disclosure: I'm not an attorney, I'm a physician. Also, I'm an AUPH investor, so probably not too bright...
Any milestone payment associated with CHMP positive opinion or EMA approval?
Two months
I would take $24 from a Japanese pharma in a heartbeat right now
Yeah, remember ponatinib. Country-by-country reimbursement negotiations dragged on forever. I seem to remember France being especially slow.
Yes, but for oral explanation, not for opinion. If all goes well, positive chmp opinion in AUG, then EMA approval in OCT/NOV
Intention to treat principle
Congratulations KZR on their phase 1B open label, single arm, 29 week study! But are you sure it wasn't the steroids? 9 mg/day at completion.
Also, what happened to the 4 patients (20% of total population) who dropped out? And who, by the way, were excluded from the data presented.
CEO still under water on his big buy, even after this move
Just a little tinge of red on an otherwise massively down day! Cheers y'all!
$AUPH Couple thoughts from today's ER/CC...
— JG (@BioLunacyJG) May 10, 2022
Not concerned much with actual Q1 rev, much more interested to see strong rebound after Omicron subsided...tells me both prescribers and patients happy with drug.
• My discontinuation, tolerance, & adherence concerns alleviated
1/2
21.6M is pretty anemic. 115-135M for the year really is starting to sound "aggressive"... I guess PG was right.
Thank goodness for BHVN-PFE news today, will take a little pressure off
So you're saying that there is hope for Frankie B and his big KZR purchase (at $15-17).
Just voted against everything in the proxy vote. Showed them! Felt good
Dyslipidemia is common in SLE. This was probably requested by EMA