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No sure what to expect.
I’m going off it’s start date of 1/8 + 56d =3/11/21
https://clinicaltrials.gov/ct2/show/NCT04701528?intr=Voclosporin&draw=2&rank=9
An open-label, 56 day, single-center, exploratory, proof-of-concept study of the anti-viral effect of voclosporin (VCS) with an extended safety !!follow-up of 1 year.!! Study population are adult KTRs with positive SARS-CoV-2 infection with mild to moderate symptoms. At study entry, subjects are on standard therapy of dual immunosuppressive treatment of .....
Estimated Primary Completion Date :
March 25, 2022
- 1 yr follow-up= 3/25/21
In the trial announcement and summary above it sounded like they already had 20 pts, the 3/25 date seems to support assumption.
I figure antiviral effect is pretty quick assessment. I have no idea what to expect for reporting. That’s why I’m asking. I work in sports tv. I’ve watched nwbo announce data lock in October after 14yr p3, and still no info.
I’ve got 1/8 + 56d = 3/11
For covid results. Listed as finishing 3/25/22, but thinking that’s including the 1 yr follow. So 3/25/21? Not sure what to expect. Will there be an interim data release? End of March? Later?
I realize it doesn’t really change anything if not successful, but really don’t want a negative pr. Don’t know if we can take it.
Quick question, not that anyone will answer, but how long from approval does it take before a pt can fill a prescription? Realizing there are many factors, but would love to see pr next wk of 1st script filled. If thats even possible. I thot i read they had inventory on hand in dec for launch but can’t find where i read.
Also, was it someone here who mentioned ERYP, or does anyone have any thots on them? Tia
Did our fda meeting not start til 6:30pm last night? Seems late, but thats when they halted. Other Friday decisions i’ve been in came at eod(4pm). Just wondering if there’s anything to the info hold til after after hrs. and should i waste my w/e trying to read into it.
Recruiting, Enticements, compensation, training, fleets of vehicles, marketing, support, rewards. Reps are needy sob’s and still they whine like they dig ditches all day. Whole different ballgame. Give me 4-4.5b and I’m tickled, 3.75-4b for speed is acceptable. Bag it, tag it, laugh about the Canadian winter on a beach somewhere.
I know pura vida mentioned hznp as likely suitor of auph, but my gosh. They beat earnings est by over 50%, sales too. Up guidance By 25% for This year. Announce improved response rates in trial data. And you drop 3%? What else could they have done? If all that drops you 3%, what will expected fda nod bring for auph?
What about VOS? Same as non-LN voc?
And do DES results affect Merk pet version? Cause my dogs are still on Tac.
Am I reading this right:
At study entry, 20 KTRs testing positive for SARS-CoV-2 and CURRENTLY on dual immunosuppressives of prednisone and tacrolimus will be randomized 1:1 to remain on tacrolimus or be switched to voclosporin.
I’m reading that as they have 20 already. And this is starting immediately. Is that how you read it? Do we start the clock now @ T-56 to 60 days?
Many had questions about voc vs covid, we’ll find out. On immediate terms, does this halt any BO potential til results? Granted it’s a small window @ 2 months, and all before pdufa date.
Guess we can add at least one more catalyst to calendar. Publication of info from LUMC. And potentially another if study gets good results. 56 days and it sounds like they already have the 20 patients would be about xmas/new year time.
Gotta like this.
Preclinical data, which are being readied for peer-reviewed publication, from our institute in Leiden have demonstrated voclosporin’s superior potency in vitro against SARS-CoV-2 compared to tacrolimus.”
Data may not have changed, but the understanding & implications are new & significant to me.
At the recommended therapeutic dose of 23.7 mg twice daily, sex, body weight, race, age, serum albumin, total bilirubin and estimated glomerular filtration rate (eGFR) demonstrated no clinically relevant effect on voclosporin’s PK parameters.
and
The linear PK profile of voclosporin allows the use of a pharmacodynamic approach instead of a pharmacokinetic approach, in which the dose of voclosporin is adjusted in response to decreases in eGFR.
Means no counter testing/dosage +\~.
4 things from that for me are
1) on kinetic approach, fda doesn’t have to validate/approve testing and corresponding adjustment protocol. (Easier for fda & doctors)
2) validate responses to adjustments (easier for fda & doctors)
3) little to no need for Dr visit for refill which Benlysta will likely require. (Easier on Dr/patient/sales)
4) label/2037 protection seems highly likely.
Imagine 1&2 are why they see no need for Adcom.
All make a case for early/pre pdufa approval.
There’s been a guy on ST saying most early approvals have come between 70-90 days? from nda acceptance. Had a quite a few followers. Think we’re at day 90 something, he has a count up. May be a few of those losing hope in early approval. Just a guess.
Finally some pub. Just take something to get this moving. Now we need company to throw a pr about something to keep going.
Wow, never seen them waive the advisory. Says a lot, and adds a little bargaining power if they go for BO. What about dosing protocol? Is it incorporated to extend?
I assume they shorted it down, w/ intentions to buy back on way up? So did halt catch them halfway? Assume if it gaps up in AM they’ll get crushed? Hoping so. Hoping they’re just as puckered as i am.
Same. Last week and some today.
The unrealistic optimist hopes it was a stop loss raid, the realist says just get it over.
Looking like after close.
I will say the sequence is remarkably similar to Amarin’s last news, minus the drop.
Irony that Star wars ran all weekend?. Is this The chosen one, to bring balance to the force. Kills us all and leaves my world in darkness
Assuming it’s punishment for promising results by Christmas & not delivering? Ppl expecting pop, didn’t happen & mass bail. Or then again they’re halted for news. Maybe it is a leak.
OT. New naming system.
I’d like to thro the idea of adopting the middle earth type name introductions.
I’m poshfox, son of $6 Auph, son of $4 Acad, son of $.11 Usga.
Shorten all ‘ been here since..., and was here before that’ stuff. Not complaining, just be shorter to type and read, concise and direct.
I’m with you Newbie. Diversification is the greatest sales tactic mutual funds ever invented. My profile shows my investing style. Kamikaze.
My guess
Not a buy in, It’s a bail out. %short =% issued =cya(covered your a). Try buying 12+\~mm shares at the market.
Two birds,
What are your thots on Audrey trial?
Success here can’t hurt recruitment. Says 5/30-7/30 for completion. Any chance that comes fwd? Any chance of a BO before? Normally I’d say no way til Audrey results for higher #, but since they’ve already shown @ .02% better than Restasis, the DES value not a complete unknown
TIA
Sorry, misread title as clinical data, not preclinical. They usually book as earlier data & then add new, i read as they booked it for this, before release.
Still, I don’t feel like I’ve ever been in a stock where such a binary event seemed like such a forgone conclusion. From company statements, then big call options, price rise, etc. Seemed like such a slam dunk that it was too perfect. Too obvious. Started setting off alarms. Thanks to those here that reaffirmed the faith. You really can’t argue that p.
TD A says Halted for pending news. Here we go.
That’s one head scratcher. I’ve never seen a co. promote a presentation on trial results before publishing trial results.
I guess my point was that everyone is thinking that final results will be released at the 3/12 conference and i didnt think the company has a choice on final results. Now they can give us an update to ongoing trials whenever, but final results or info from fda can't be held to release at a conference. So basically the conference has no bearing on data release. Or am i mistaken? I know cur has thier trials set up a little different than most, but wasn't sure. Thanks for reply.
I thot there was a regulation that material events/info has to be released within 72 hrs. I didn't think co's could sit on info indefinitely until they are ready to release, like at a conference.
Same here. Back in. I'm playing a risky game, finger's crossed it times out right. Come on CUR, bring the noise baby. Daddy needs a college education.
One thing that stood out to me is that i've seen multiple news articles about the sci trial that state the 1st patient has already been discharged from the hospital and gone home. Seems crazy they would be home within a week.
Wondering what to get that diehard Cur investor for Christmas?
http://www.razata.dk/home-garden/science-photo-library/neural-stem-cell-culture-framed-print/c~4z9wwgmbee8dz3
Little help pls.
If the Russel indexes are adding 6.5 mil shares, where will they come from ? The company direct ?Can't be an open mkt buy, price would soar, so are the mm's accumulating those shares now ? Does Cur have an ATM option for selling shares ? Am i the only one who thot the action leading up to teusday was odd ? I've never seen sp action like that b4 news w/out news being negatve.
With the presentation not until after mkt close, r we thinking pr today or tomorrow?
Another theory.
Someone on yahoo was talking about K. Palko walking 98 feet, but that they have to keep it quiet as to the source etc, etc. Palko was the final patient of the second to last cohort, the one that just finished on 4/16.
I'm wondering if Mr. Palko is going to WOW the crowd with a walk to or from the mic on Friday the 13th. Hope he breaks a long one down the middle.
18th Annual
"Evening of Hope"
Friday, June 13
Garden Pavilion - Crowne Plaza Hotel
Warwick, RI
honoring
Kreg Palko
with the "Brian Dickinson Courage Award"
http://webri.alsa.org/site/PageServer/?pagename=RI_homepage
Ps. I don't know Mr. Palko's condition prior to surgery, but if this is a big deal(i.e. he couldn't walk this distance before surgery) and it sounds like it is, then that means we are seeing some serious results within two months of surgery in that first full dose cohort. That bodes seriously well for patients and BTD.
Godspeed Mr. P. Show them what the future holds.
I am a bit new, but ive never seen a dbl blind, placebo controlled p1. Thought that was usually for p3's. Is that normal and i just never noticed ?
Sorry, should call it safety monitoring board or SMB and not panel.
From the trial description:
"The study will proceed successively from Group A to Group E with a 4-week interval between Groups. The Safety Monitoring Board (SMB) will be convened at the end of the 4-week interval and review all available safety data...."
"The SMB will consist of 3 neurologists with expertise in ALS, 1 spinal neurosurgeon, 1 neurooncologist, 1 transplant immunologist, and the scientific director of the ALS Association."
Actually i was thinking of this exact day or the 8th, but i built in 2 days for possible delays. It is a meeting and they can get pushed like the one in march. They have usually been on the 28th day exactly, but march fell on a friday i think, and it happened on Monday. There is no doubt to me of the link. It times out with the Christmas run, the march jump, and now today. Three runs on no news that all time out. Besides, you can't ask the science director for the ALS Assoc to not tell some coworkers of good results. We're talking about hope where there is none. It's cruel to expect people to withhold that from others.
If history holds, Emory will have the first patient of next cohort done within a week. Let's hope the other two cites are as prepared.
I'd like to ask if there will be a panel review between the 1st and 2nd half of this last cohort, or will they just do all 6 surgeries. This may have been the last one since this is the last cohort.
Palko2 was 6 days later. 5/8 + 6 = 5/14. Whats todays date? Tell me u see it pgm and that I'm not crazy. Im new to all this and i need a victory lap. Ha
My call for late feb was off due to unknown (to me)weather delay for last patient/1st mass patient which didn't occur til feb 10 i think. Also remember they aren't pr'ing surgeries. Only reason we know palko is family blog.
28 from last surgery is earliest. That would be palko1. Palko had 2nd surgery on 16th to relieve swelling = palko2. Also there is some flex due to patients having to come in for 30 day check ups. Thats why my call said as early as 5/8 thru this friday depending on which palko date they used.