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Showing posts from June, 2017

Week of June 12 2017. Up from here?

Changing post from daily to weekly. Hopefully this will make it easier to follow the conversation. We will still continue news and special issues on an ad hoc basis. Let us know what you think!
We've had a hard time as of late, stock price down from 10 to 6. Painful. The question is, without any news how long and how low will we continue to sink?
Hang in there everyone.
TC


June 9, 2017: Early Approval Redux

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 alist of drugsthatreceived 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 endpointhat 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 study the drug further, to verify…

June 8, 2017: The case for early approval of Voclosporin

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 alist of drugsthatreceived 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 endpoint 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 study the drug further, to verify…

Wednesday, June 7, 2017. Could AUPH phase 3 trial be terminated early because of GOOD results?

Yes. 
This is a preview for tomorrow's discussion where we will explore a number of key questions, including:
Why is the Phase 3 protocol almost identical to phase 2, and what does this suggest?What do we learn from 2017 FDA report that describes 22 P3 trials that had different outcomes from P2?The odds of for all autoimmune treatments succeeded in P3 is in fact 62%. So what is the statistical basis for the case the odds are much higher for Voclosporin? I clearly don't have all the answers here, and will need your help so we can all improve our understanding of these issues. Doing so will allow us to improve our risk/reward assessments.
All the best,
TC 




June 6, 2017. Buy Out at 63?

Take a spin on our BO pricing model!Our model is generating a range of $35-63 BO PPS, per the low/high case scenarios below - where only the Voc price is different (25k vs 50k). My hunch is that this is both conservative and in the ballpark. 
It's conservative b/c: 1) patient population is consistent with Aurinia's projection; 2) assumes only 35% of population on treatment; 3) assumes 75% discount for European market; 4) pricing is at 50% of range projected by Aurinia; 5) uses target P/S ratio of 3, which is below Biotech industry average of 5.0. 
OutcomePatient Pool (Same for both Scenarios) PricingPrice/Sales ratioHere's the Link to the model

Low end BO PPS w/30% discount: $35 ($50 no discount) High End BO PPS w/30% discount $63 ($90 no discount) 
Prev: 26.5 per 100,000 (Based on epidemiological study)  Total Patient pool (US, Europe, Japan): 252,333  % of patients on treatment: 50%  Total Patients on treatment: 88,317 

Low: $25,000 (50% of Aurinia low end)  High: $50,000 (100…

Monday, June 5th, 2017 BREAKING NEWS and Tute Ownership

Institutional investors quadrupled their ownership this year. VOCLOSPORIN  is BETTER than we thought!! New analyses of data reveal the power, as the press release notes:

“We were very encouraged to observe that voclosporin therapy resulted in significantly improved remission rates without compromising renal function and blood pressure or inducing electrolyte disorders,” stated Dr. Tumlin, Principal Investigator. “Prolonged steroid therapy for lupus nephritis is associated with unwanted side-effects, and a reduction in steroid dose should be a treatment goal. These encouraging data suggest that voclosporin can induce clinical remissions with low dose steroids while minimizing renal toxicity.”

This should explain why tute ownership is way up!
Check out this website to see how tutes have nearly quadrupled their ownership over the last five months.  This should assure you that you're on the right side of this bet as a long, and that the shorts are just playing with fire. Hang in there…

Friday, June 2nd 2017 - and a disclaimer about the purpose of this "anti-blog"

Auphie loves Friday! This is an "anti-blog." Folks, it was noted by a kind poster on ST that there's not much content here. That's by design.  This is an "anti-blog" which is intended to provide a place for Auphians to share ideas without the risk on iHub, i.e. domination by trolls and heavy handed censorship. From time to time, but not often,  we will push some content. But otherwise, this is YOUR place to share ideas, safely, about AUPH and not be limited by 140 characters.

Kind regards to all,

TC