Seemingly, the company is happy about that their PPS has just down 20% since approval with their silence. They may report till 30% down -- just 10% more to go.
Daily lower low, lower high and lower volume. The trading range is so narrow even day-traders couldn't make money.
If today's volume downs below 1M, tomorrow, and the day after tomorrow, will be another down day. Death spiral.
Keep going till gone.
I am with you and other science-believers. Not posting too many -- not too much doubts except FDA's "show me." Anyway, REDUCE-IT will slap FDA (thousands will die due to ANCHOR delay), but we have to wait, perhaps silently.
I am interesting in the long and deep silence after Northera (droxidopa) approval.
Droxidopa is an inhibitor to several D-Receptors. It has been in Japanese market for 20+ years by Sumitomo Pharma and in a few another Asian countries as well. It is not a big drug -- annual sales was peaked around $50M in Japan.
It is a CNS drug able crossing blood-brain barrel but with minor reported side-effects in Japan. This old drug has never been systematically and carefully studied carefully previously due to it was approved in Japan in last century.
Said so, FDA's conditional approval with the block boxed warning and the requirement of a long-term large-size conformation study is a surprise to many (to the company as well, I think -- I believe that the long and deep silence states the surprise). The company is not well prepared for the situation. Buyout/partner? What is the right valuation? Launch the drug? Cash position is too weak and a lot of pre-launch works have to be done. The long and deep silence also states the confusion inner the tiny company.
Anyway, the company have to break the silence, not "if" just "when".
Cramer's RA comment is just indicates his bad mouth, nothing about droxidopa's potentials.
With those potentials you mentioned, the upcoming "long-term efficacy" will be much more critical than ever. "Long-term" versus "short term" is, scientifically, about the tolerance. Seemingly, the product would be a controlled substance and be scheduled by DEA. If the tolerance will occur after a two-week treatment, the product could have strong potential to be abused and costing lives. So, a study of 6y and 1,400 patients is critical.
No pain, no gain. CHTP is experiencing the pain first. Gain? 6y and 1,400 patients will tell.
Without Orange Book settings for Northera (in fact, no "Northera" or "dorxidopa" can be found in Orange Book), any buyout/partner talk is just talking the talk. March update of Orange Book will be on March 15th.
Waiting for Orange Book Update. In the presentation in Wedbush Conference in August 2013, the company stated a relative larger patient population in contrast of Orphan Drug. Perhaps, the company is not sure about the ODE.
In fact, CHTP has had three major weakness:
1) Weak product (in both efficacy and safety) -- needs 6y, 1,400 patients and $50M+ to answer the questions;
2) Weak cash position -- no matter GIA or Partner, $20M cash just to weak. The secondary should be done at a higher price (say $5) with much more shares (say 20M shares);
3) Weak marketability -- GIA needs 100+ reps costing $20M+ per year, and the sales will be about $10M in the first year.
Looking at the chart, there were two gaps as the PPS went up, the first was from $3.5 to $4.5, the last was from $4.5 to $6. If CHTP keeps silent (i.e., no confirmation of a buyout/partner) or decides to go-it-alone, the PPS may fill the last gap first in the near future (down to $4.5). Any further bad news from marketing, the PPS will be easy to back to below $3.5.
Given all the info, it is hard to pick the long. The efficacy (long term) is still in question, and safety (Black Box Warning and risks of stroke) is also in question -- 6y and 1,400 patients to answer, and the study need $50M+. These concerns limit the possibility of clinching a buyout/partner. If GIA (go-it-alone, no matter by establishing a sales force or hiring contractors), the $20M cash at most can get into 2015.
Could someone (epadruginitiative?) initiate a private donation to support REDUCE-IT.
In AdCom, Dr. Selly called for financial support to finish the un-precedent outcomes trial.
A private donation will humiliate FDA and society.
I promise that I will make my donation.
Seemingly, the company has to use their resources to fight FDA in courts and keep RI going. Otherwise, they would do ads (paper, internet, radio and tv).
The product - Northera could be a valuable one for unmet medical need. The killer is the poor development: Black Box Warning, Stoke Risks and Long-Term Efficacy (1,400 patients, 6y Phase IV) -- these stuff should better be taken care prior to marketing. But the $20M cash (totally from preapproval secondary) tells -- sickly funded - the BOD and MGMT are sleepy.
With the serious uncertainties, CHTP has no way to clinch a buyout/partner. $20M cash is a peanut. Another secondary? How low? Even low enough, how many shares? CHTP has no way redo another $20M, and another $20M is still not enough.
In Approval PR: "The package insert indicates that effectiveness beyond 2 weeks of treatment has not yet been demonstrated, therefore the continued effectiveness of NORTHERA in patients should be assessed periodically. A multi-center, placebo-controlled, randomized study, which includes a 4 week randomized withdrawal phase preceded by a three month open label run-in phase, designed with the goal of definitively establishing the durability of the clinical benefits of NORTHERA, has been preliminarily agreed to with the FDA. Based on the contemplated study design, the trial would include approximately 1,400 patients, which the FDA has agreed may be enrolled over a six year period." -- serious uncertainties ahead.
Seemingly, the company is seeking a partner/buyout. However, the company may not able to have a mediocre upfront plus royalty. If the company wants to market the product, $20M cash is not enough -- a sizeable secondary offer would be up in March.
In AF's article, he said "Vascepa may never see generic challenges due to the small sales numbers." Actually, it is a soft bashing. He was bashing /laughing on current sales not coming generics.
In fact, the facet of Vascepa's sales is controlled by FDA -- "potential overuse" was a hot topic in 2013 AdCom in "justify" of limited Vascepa with MARINE. So, "poor sales" and "rich sales" just depend on FDA's attitude towards ANCHOR (or REDUCE-IT). Any greenlight will transfer to sales at anytime.
Even a few $10M sales is still smelled as "blood" for generic drug makers. TEVA, Actavis, PAR and Apotex are the big names in generics. They will try -- nothing unusual. However, the difficulties in purifying EPA (and it is patented) could set a high bar to them. That high bar is the real reason of possibly no generic challenges in the near future. But a generic challenge will finally be there anyway -- nothing unusual.