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Nihander, where are you getting this info from
Halted again, ridiculous, let it rip, why halt it every time it tries to go up !!
Where did you get this Info Nihander ? please provide link
yeah I know, I hope we get the data next week. I understand that time is required to add more secondary results, but you can see that people are getting impatient here
Here we go boys, I have a feeling this is the big one
Slide 37 and 38
Something interesting and new that they added this week on their presentation, I think they added it this week because I didnt see it before. They put a note in red on the chart where they compare the severe capre of trifecta to the Marine trial of vascepa. The note says that the real lowering of TG achieved with vascepa was 27% and not 33% because 10% of it was placebo effect. I think this is them saying we didnt beat 33% but we did beat 27%. This is big imo
just a comparison to Vascepa, they reduced TG by 7% with the 2 g dose in the MARINE trial (severe HTG). Pierre the COO and CSO mentioned in his last interview that the Capre 2 g reduced the TG by 15% in the severe strata in the Trifecta trial. so if we were able to achieve double reduction with the 2 g , even with a small sample of patients, I don't see why we cant do better in the 4 g
will take a look Watson, a bit early for summer .
I am focused right now on ACST to see how this P3 will unfold.
lots of drama going on in the last week. waiting patiently for the T1 numbers and my expectations are HTG delta between 29 and 31% at least(which is great compared to VAscepa 33% which accounted for 10% of Placebo increase) + achieving a meaningful delta in HDL, Non-HDL , VLDL (beating VAscepa)
keeping in mind that HTG can fluctuate 25% over 12 weeks in normal patients (and even more in severe HTG patients), achieving a delta around 30% is a great achievement, add to this unmet (by other competitors) improvement in the other lipid management measurements makes Capre the go to drug
JB, I guess we need to add another week to the timeline mentioned in the update you posted, because we need to take into account the delay ACST mentioned in their PR
Thx JB, very informative. This confirms what I was told by a longtime shareholder that that delay was decided following Haywood recommendation. It also confirms my suspicion that the real leak on the TG numbers happened on the week of Dec 16, confirming the trial success
The leak will happen, unfortunately. I spoke with someone who confirmed that he got a heads up about the delay an hour before the raid on Dec 23, so I think we will have a leak. but imo, the real leak has already happened the week of Dec 16 when we had a whole week of green, and if management had better communication skills we would not have had that dip last Monday.
yes, company mentioned in their latest PR that the data is now with the statistical consultants, so if those guys come back to work on January 5 (the latest) , they won't need more than 5 days to sort out the final results.
LDL and HBA1c will be in March because they need to include both studies in the results to have more power, the rest should be issued with the Topline numbers
i am expecting results second week of January. this will reduce the timeline between T1 and T2 and limit any profit taking after T1.
I also think that scenario 3 is the most likely, I don't believe there is any game played here by mgt. Xmas timelines are tough to meet , so they got delayed in processing, ok, we shouldn't overthink it. Now the leak that there was a delay is what killed the trading. Many people knew about the delay an hour before the raid so some used this info to hit all the stop losses and margins. In particular there was a poster on a different board who admitted he knew about the delay before the stock sold off and knew the content of the PR before it was issued by 2 hours
After rethinking this with a cold head here are my observations
1) they met their primary endpoint of delta higher than 20% , there is no point of issuing secondary numbers if the primary endpoint fails
2) it is possible that their delta is above 20% but less than 33%( vascepa) so they want to add the secondary success to show the trifecta effect that vascepa does not have, hence the delay waiting to get those secondary results
3) it is possible they really got delayed with the data processing and forgot to pass this info to the market ( I understood from someone they had the Xmas party so they forgot to issue the delay ), in this situation the original spike was the results leak coz by Friday they knew the results but needed the statistical consultants validation
In all scenarios I truly believe the primary endpoint was met
I sure don't know what happened yesterday, definitely company dropped the ball communication wise but today's trading seem ok with a green close, I am still bullish and waiting for results.
Still here guys, shock shelled by what happened today. I blame mgt for not announcing this delay earlier, and I hope it is just the technical delay. Will see in January
Perfect. Just to give you an idea about the value. AMARIN is an $8 B company. We are $240 M with 85 M shares. If we even get close to Amarin results , you get the picture :)
Also we have impact on LDL , HDL, and HbA1c related to diabetes patients ( we have 45% of the trial patients diabetes). Amarin has no impact on any of those that I just mentioned, so we get the same numbers we got before for them and Amarin is in the back mirror
Sorry Maciste I just checked the site and saw your post, I hope you bought before market close , you never know if they issue results on Monday before open
may be today after market close or Monday morning before open, it is trading like they are almost ready to issue the news. also we only have 85 M shares so 20 USD which is a 10 bagger takes us to 1.5 B value only. huge upside here
i hope we get some news today after market close. they DID say results before Xmas
looks like you guys jumped in at the right time :)
no worries Mkc, nice run in the last 4 days. was comparing this to the NDA of Vascepa (see the link attached). just for comparison we achieved over 21% mean % change in the 4 g in COLT at 8 weeks , and comparing to Anchor(Page 53,54) ,the maximum mean delta was over 20% ,(and they were all on Statin, while Colt had 30% only on Statin, Omega 3 works better with in given with Statin), so I am really excited about the Trilogy I and II results. seems Capre also is more Potent when you compare the Mean results of Anchor and Colt ( in Anchor the maximum delta was attained at 4 weeks and slid from 20.5% to 17.5% at week 12 while in Colt we jumped from 15% at 4 weeks to 21.5% at 8 weeks, which bodes really well for Trilogy II). GL
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
as per the interview, results are before Xmas
very interesting interview with Acasti, pretty confident they will nail it
https://ca.proactiveinvestors.com/companies/news/907910/acasti-has--put-its-finger-on-something-very-interesting--in-new-data-updates-on-trilogy-trial-907910.html
No problem, huge upside if they hit their preliminary endpoint and show something close to Vacepa numbers
Yes Newbie, bought yesterday after doing my DD, and I like it. their P3 results for lowering TG is due any day now. we can discuss on the ACST board, I don't want to spam the AUPH board
Hi Guys, a new Tip with results P3 anyday now, ACST if anyone is interested
Hi guys, took a position yesterday, GL all
“The positive results for the AURORA Phase III study of voclosporin is the news the lupus community has been waiting for and represents a remarkable breakthrough in efforts to bring a better quality of life for the more than five million people worldwide living with lupus,” Stevan Gibson, CEO of the Lupus Foundation of America, said in a statement.
strong endorsement
41 M shares traded, 10 M of them were short so 31 M shares took profit today (31% of the total float )
No worries about the offering. The last one they had was for 40 M and the already raised 15, so if they go for the remaining 25 that is 1.5 M shares at $15 SP.
also I doubt they raise more since they mentioned they had 130 M in the last CC.
Remember last time they were almost broke so they had to go with that big raise of 150 M in 2017, this is not the case now they have 130 M in the bank
lots of long term holders found this news as a liquidity event and sold their long time paper, it will bounce back. this pull back is normal after a long hold imo
yes I did, he was talking about generics if I recall, in summary he was saying forget about it , no generics will be made for this drug
yeah, even the Eye Syndrome, Neil was saying in the CC in Nov that the dose they used in the last trial was not even close to being the optimal dose (and look at the results they did with that), so there too they will make some waves on the Eye Syndrome issue
Analysts are already saying expecting $ 3-4 B company
https://www.cnbc.com/2019/12/05/aurinia-more-than-double-in-one-day-after-positive-data-for-lupus-drug.html
i am putting here my opinion regarding AUPH
1) first things first, SAFETY , incredibly huge endorsement for the use of the drug. we have 2 options here:
1.1) the 5 death in the Placebo were caused by worsening SLE disease and in this case this is huge for AUPH because we proved we were able to limit the disease worsening with VCS
1.2) the 5 deaths in Placebo were caused by AEs and in this case there is no points for us since it could have been the other way around if those patients were in the VCS arm ( it happened in AURA).
so Either way we have proved we are as safe as SoC and even we could have saved life if 1.1) is the case
2) Delta is 18.5% but the real delta should be around 25%. why:
If you look at the 24 week results you see that we had the same numbers as AURA at 24 weeks (32% VCS vs 19% Placebo) so the difference happened between week 24 and 52. what changed here can be explained through 2 scenarios:
2.1) A major criteria which is the increase of steroid dose prohibition, shifted from week 16-24 in AURA to 44-52 in AURORA , this means you can't adjust the steroid dose during these final weeks for patients showing a relapse ( it was one of my main concerns in my previous posts and i suspected that the 100% rate of those who stayed in CR between 24 and 48 weeks will not be met in AURORA).
BUT, in real treatment conditions this is not something that will happen , the 44-52 weeks criteria is only for the trial only , in real conditions a physician will adjust the steroid dose to put a relapsed patient back in a CR condition (as long as he has responded initially to the drug) so basically we really should see the AURA % which was 49%
2.2) the difference of 8% between week 24 and 52 instead of 16% as in AURA was due to patients who were in CR at 24 weeks but quit due to AEs (and this happened in AURION 2 out of 7 left due to pneumonia and high fever when they had CR). Again, in real life this is treatable, the patient will not quit a treatment for AEs if he is responding to the treatment, there are a lot of ways to treat him to put him back on track, so the real CR rate should also be 49%
all this to say that the real Delta is 25% as AURA because the most important parameter is CR at 24 weeks (same as AURA) and the total responders (70% same as AURA). those responders at some point will turn into CR.
so when you account for all those exceptions, you see that we are not far off from where AURA results were except that we have a better safety proof. the only thing that remains now is the long term Nephrotoxicity impact because this will define if VCS will be a chronic treatment ( valuation over $50)or a temporary one. so far, all the signs point that we don't have a long term Toxic effect (eGFR levels go back to baseline levels after trial finish) and even the side effects (lipid, glucose, high blood pressure) were not encountered ( the TG and cholesterol went down actually as per Neil in the CC).
a quick comparison to Roche drug, we are way better since our response is way faster ( Roche had the CR rate of 24% same as placebo at 24 weeks and we have 32.5%). our CR is attained in 7 weeks when it is in 12 weeks on average with placebo and Roche). the Speed of remission matters a lot to physicians so we are the best in this domain ,and by far imo.
Full disclosure, i am holding to all of my shares because this has just started, give experts some time to realize the full potential especially when they start publishing the data in conferences.
GL all