Voclosporin will likely be approved well before the P3 trial runs it course. Here's how it's going to work. First, there's a legal and regulatory path for this approval . While I quote the relevant passage below, here's the link to the FDA Regulations , as well as a list of drugs t hat received accelerated approval. Sec. 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoin t that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant stud
This decline is meaningless and was predictable after the offering. It will probably go on a couple of more years unless we are acquired before the end of the study. Most of us will be gone by then, but not the few true believers who can and will sustain anything and are prepared to go down with the ship if necessary ( I recently watched a company I owned go under but that's the breaks). I would be shocked if Voclosporin does not replicate its safety and efficacy in phase 3. Waiting a few years is nothing when we know the buyout may bring us millions (with an s). It's ok to try to decipher the tea leaves and predict the future here. But unless there is some actual factual change in the status quo, I am quite content to let the process play out and let this dead money rest in peace until it is resurrected one day by an incredible buyout which can happen when we least expect it.
ReplyDeleteYes, true. The ride with exhaust most retail investors and, like with Ariad, we will end up with 95% or more institutional investors and a handful of retail die hards. The challenge, I think is to forget you have this investment. I'm not there yet.
DeleteThis comment has been removed by the author.
DeleteThe vibe is definitely down here this morning. And even Vid owns in companies that go belly up?? This monday couldnt be any more mondayish.
ReplyDeleteMy only non biotech went belly up. I bought it on the advice of a friend but I never really understood the science behind it. I have a science and psychology background and I have been investing in biotechs for 25 years. More importantly than understanding the science imo is to understand the psychology involved in investing in small biotechs, and having the patience to wait out the necessary time after you find an undervalued company
DeleteI learned a good lesson on the non biotech that went belly up. Never invest in anything you dont understand.
Gotcha. No faith lost here.
ReplyDeleteAnybody still holding ARRY? I reopened a modest position after getting spooked by Denner. Reading up on it again, and it too is a promising company.
ReplyDeleteI hold a small position in arry. If Auph got bought out tomorrow I would use the cash to increase my position in arry and plx
ReplyDeleteARRY is a great company and therefore subject to the same bullsit as AUPH
ReplyDeleteLast month I started a thread on Ihub related to P values, regression and such. It was an interesting discussion with several informative posts.
ReplyDeleteIn a couple weeks I am spending some time with old friend who teaches statistics at a prominant college. I've warned him I need to have a serious discussion with him on subject of P values and how they are to be interpreted in biotech drug studies. I'm bringing the print out of Auph P2 results. If I'm able to pick up anything worth passing along I will certainly post here for all to comment.
Thanks. I took stat some 45 years ago and loved it but would appreciate an expert giving us his opinion our P values
ReplyDeleteCan anyone confirm that Omeros treatment for nephritis is not effective for lupus nephritis which I read in an October 2016 article about Omeros?. The twits on ST seem to be concerned about Omeros as competition for Voclosporin but as I recall the two LN patients in Omeros' phase 2 trial did not benefit from their monoclonal antibody treatment and the fda BTD was not for our indication of LN
ReplyDeleteOmeros is pursuing IgA, and both their BTD & Orphan status are for IgA. They only had 4 LN patients in their Ph2 with mixed results. It looks like a promising drug for other kidney conditions. I imagine their Ph3 will just be IgA patients, while their Ph2 had 4 different conditions. Their drug is currently IV administered with hopes of eventually making it into an injection. It's expected to be priced at $100k so off-label use for LN seems unlikely. It sounds like it could be a good combo drug with Voc if it wasn't for the price tag...that's my thoughts anyway.
DeleteThis comment has been removed by the author.
Deletehttp://www.proactiveinvestors.com/LON:IMM/ImmuPharma-PLC/
ReplyDeleteLong AUPH and first time poster. Just wondering if this company - ImmuPharma - which trades on the London Stock Exchange represents a threat to Aurinia Pharma?
Just took a quick glance, their drug is for Lupus (SLE), not Lupus Nephritis (LN). Not a competitor, but looks promising for Lupus patients in general.
DeleteVoclosporin, on the other hand, may not only be great for LN but also lupus in general. It will be interesting after approval to see if physicians start to prescribe it off label for lupus patients without LN.
DeleteThis comment has been removed by the author.
DeleteToday's SA article (6-15) is way over my head. Hoping the Auphians will shed some comprehensive commentary on it. Thanks in advance for any elucidation:
ReplyDeletehttps://seekingalpha.com/article/4081814-therapy-focus-lupus-hopes-build-data-remain-distant-horizon
cheers
Looks like a poorly researched article clearly showing favoritism to specific tickers. If Auph actually had a legitimate competitor, the shorts would be announcing it to the world.
DeleteHa, well that wouldn't be the first time they published garbage. Was it not SA that published that hit piece which stated that biopsies would be required...which resulted in a double digit decline?
DeleteIt would be good to hear something from management. It's been awfully quiet since the start of phase 3. A few leaks on an early BO would help tremendously.
ReplyDeleteWell you're in luck, we should see a PR very shortly...most likely conference related though.
DeleteThank you Mr. Glickman for reading my Auphian post...🤓
DeleteThis comment has been removed by the author.
DeleteAny reason for the bump today?
ReplyDeleteAuph presented new data at a conference today. What we knew is that Voc is twice as effective vs. the current standard of care, what we now know is that it works much faster as well and patients from Ph2b were in remission twice as long.
DeleteThis comment has been removed by the author.
ReplyDeleteToday's news will be very welcomed by the medical community. Not only does VoC get twice as many patients into complete remission, we now know it gets them there significantly faster and keeps them in remission. This is big news because of all the scrutiny over medical costs and trying to keep hospital re-admission rates down.
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteDone, and thanks for that. Pruning anology works. Don't want to censor, and will push back on that - everyone should. Just want to make this a safe, healthy space sans trolls and monsters.
DeleteOpen to suggestions as always.
TC
Well done
DeleteKey data point from Friday's press release is that for Voclosporin, the duration stat can continue to increase. The CR rate increased from week 24 to 48 by 60%, so those patients can increase the mean duration of the CR for the entire treatment arm.
ReplyDeleteThe only thing new that I heard in today's AGM was the announcement of an R&D day this Fall to discuss "the additional potential of voclosporin;" aka additional indications. Something to look forward to, should be interesting.
ReplyDelete