1. Mineral oil placebo
IMO, even if mineral oil were shown to stat sig increase primary/secondary endpoints of ANCHOR patient population wrt an uncontroversial placebo, it does nothing to discredit Vascepa's individual performance. FDA approved the MARINE indication with little controversy (and no adcom). If they truly had a concern with regards to the mineral oil, why would they approve, and w/o adcom? Doubting the placebo-ness of mineral oil would certainly be grounds to dismiss all of Amarin's completed and on-going trials. Christ, we're talking maybe 4g of this oil... Even if it weren't "inert", actually impacting the results in a measurable way is a tall order from such minuscule amount of oil.
2. Non-inferiority test for LDL secondary endpoint.
This is the most bizarre critique in the BD. The FDA agreed to the SPA, and why wouldn't they? Currently available treatment options lead to stat sig increases in LDL, wrt to placebo, w/ TG reductions. Amarin showed that it is non-inferior to placebo wrt to LDL, which is sufficient to show superiority to those that are stat inferior to placebo. Secondly, this is a secondary endpoint... Rejecting ANCHOR off a slightly different choice for comparing the arms in a secondary endpoint seems absurd... This isn't the overall survival vs PFS debate in cancer where LDL would be considered more important than TG. Not increasing LDL while decreasing TG is the entire selling point of Vascepa.
3. The #2 point here, combined with the wording of the #2 question (the voting question) in the BD, leads me to believe ANCHOR approval in the bag but the FDA is simply deliberating on how broad a label. FDA may be reluctant to say Vascepa reduces LDL (as opposed to just saying it doesn't increase LDL). Further, FDA not asking panel to vote on approving Vascepa for ANCHOR population, but rather REDUCE-IT population. This is a big vote of confidence for ANCHOR approval IMO.
Don't sell to the in-coming institutions and short covering. This is a solid long term value company that is severely undervalued. Market blows out there, you ain't going to find a better place to sit your money. Don't park your cash in other catalysts too soon, but market conditions make for ripe bear raid conditions. With gov't shutdown, less chance of early announcement anyways.
Just hang onto those shares.
Crotical pieces are always brushed off as old news, while a fluff piece is heralded. Lol, ymb is so transparent.
I think 5% is an appropriate conservative rate, conservative being the keyword. I've seen people using 50-100% higher figures.
5% of 5.2M targeted people can also be considered 20% of those who still regress with currently available treatment options (1 in 5 of those 5.2M). This will be the initial target population for C-Pulse, 20% market capture, which I think is an appropriate rate between 20-30% that is typically used for a pioneering new treatment option in a competitive field.
8% market capture would be my next level, or 30% of those who do not respond to currently available options.
Unstable angina will be come relevant once the tissue sample tests come back and company starts to put into motion the regulatory process towards getting that indication for C-Pulse.
Read wrong, it more than doubled in same amount of time, point stands though. Next resistance level after 52-wk high $15. If we break it, $20s certainly in reach.
Don't miss the gravy train.
CF companies typically trade around $250M after feasibility results. That is $15 in terms of PPS.
If we want to use conservative projected sales, 5% global market capture with estimated odds for partnerships/royalties/successful results/approval/buyout, and at a 20% annual discount from peak sales in 10 years, we come to a FV of $20 before Dec '13, $30s a year later, and $80 before 2018.
With the financing overhang out of the way, this company is set to be an epic grinder for the next 2 years. Don't miss it.
SSH will only need to raise another ~$30-40M 2-3 yrs from now. That will likely amount to less than 2M add't shs.
This has been a great move by management. They have done a 30% dilution at $10.50, which is about 30% below the 52-wk high $13.8 and about 15% below the recent higher end of the stable range in $12.5s, and yet stock is trading $0.5 above offering price right now at $11. Banks will have no problem selling over-allotment with this kind of demand.
This kind of offering could have happened anytime from when it hit $13.8 to before December '13. Shorts were and would have continued to come in every week proclaiming imminent offering until they were finally right, because it wasn't much of a surprise considering the recent bull rally and past cash situation. The fact that they got a $10.5 pricing with 30% dilution, and yet it's finding support in the $11s today, tells me that there are going to be a lot of butt-hurt shorts from under $11 scrambling for those shares in the offering. I expect SI to drop dramatically in a future report.
With this financial overhang out of the way, this company is set to hit $20s before December '13.
I kmow youre trying to sound bearish but if they managed to raise $95M at just 20% discount pricing, that wud be incredibly bullish.
In the real world, SSH will prly issue close to 3M shares, like their last 2 offerings, somewhere in the $10s, and be financially set for a couple years.
Reason for the delayed reaction to getting to fair value is due to financing overhang. With enough volume, that overhang loses its grip. We will be in $5s near term, but the overhang is having its way in the form of dilution and shorts relying on that dilution. Institutions will keep this stock rallying for next couple days. These results were not priced in, the 2nd trial was a lot harder to show efficacy for. Buy the dips.
I sold at a lower price than I bought back in past few trading days. I ain't mad, made bank and I wanted to protect profits. Saw today's action and thought that it provided some security for another move up, so I came back.
Sold at 7.98(prior today), back in at 8.05. Maybe I bought baalzibal's shares. Bounce broke through 2 resistance levels, bullish sign. next one is 9.0
Went long today on the bounce. Broke 2 resistance levels since. I think we have a stable range between 7.7-9.0 until calcitriol. maybe it breaks through 9.0 before calcitriol, doubtful, but today's bounce was a bullish sign from such an upward move recently.