A side note is that at interactive brokers the available shares to short is only 200k, so ammo is getting low, and selling pressure will be from x longs, and less blatant shorting.
A side effect like hyperemia might not be too big an issue, but without redesigning the drug it will not likely go away. My thought was to administer the drug twice a day initially or when they first notice a reduced benefit, in a sub population, to see if that gets the efficacy higher. They could do that easily without scraping the entire phase 3. I just started looking at the company, and do not know enough about the drug at this point, but adding an additional subgroup in phase studies is fairly common.
In addition, the results showed a slight loss of efficacy in the week 6 and day 90 measurements. Across the Rhopressa TM study of 182 patients, 36 patients or approximately 20 percent showed signs of loss of efficacy during the study. The primary adverse event was hyperemia, which was experienced by approximately 35 percent of the Rhopressa TM patients, of which 80 percent was reported as mild.
I think the fact the drug did not meet the first primary point was only part of the reason for the market crushing the stock, that can be somewhat worked around. The fact it loses potency over time for 20% of the patients is the bigger concern, which might make the drug far less marketable. It will certainly make for a smaller addressable market.
Also from the filing: loss of efficacy over time was reduced to half for patients with IOPs less than 26mmHg, and the frequency of such occurrence progressively decreased for Rhopressa TM patients with lower IOPs.
So their addressable market potentially is the less than 26mm group, but it really works better the lower the pressure.
I have not taken a position, but have been quietly kicking the tires, not quite sure a patch will stop this leak. Hope it works out for those out money, for now I will stay out until things clear up. Good Luck.
Thanks arlo, no, not scared off, been here about 4 plus years, I check in but there is nothing new going on so no reason to post. Earnings around May 10th is next news high light here, unless Frost buys us a new company, or announces that an NDA has been filed, lol.
public service announcement.
No, I no longer need hide an extra large potato in my pants, lol, I will be hung like a bull/a yak BULL with my own 20 ladies to sit and watch the stars, and say thank you, lol. No more did you take the garbage out, nope, I will get do not touch the young hiefer, she has tattoos, and a tongue ring. It could be good, UNLESS there is a meat market close by, lol.
If/when I get reincarnated, if reincarnation exists, I want to be a male yak, ONE male 20 females, ummm, I could deal with those under whelming odds.
The yak is a herd animal found in the mountainous regions of central Asia. The yak tend to gather in herds from 10 yaks to 100 yaks, most of which are female. There are only a few male yaks per herd.
Although there is a large domestic population of yak, there are only a few wild yak remaining . The yak is still used in many parts of central Asia, for pulling heavy farm machines and transporting large loads through the mountain passes.
The average male yak can grow to about 2meters tall, with the female yak being about 1/3 the size of the male yak. All yak have very long hair to keep them warm.
The yak belongs to the same cow family as the Asian water buffalo, the African buffalo and the American bison. However, the yak is slightly more like the American bison in appearance as both the yak and the bison have long hair in order to withstand the colder climates, the bison of the North American winters and the yak of the mid-Asian mountains.
Ok, yawn, back to watching the tick of the tape, lol,
Rayaldee side effects? The study listed no side effects. In fact the dosage of Rayaldee can be adjusted up or down to achieve the desired D level. Healthy individuals can just get sun light, or use an otc D to raise levels. Many Ckd stage 3 or 4 patients have this ability compromised.
There is a little confusion about Rayaldee, stage 3, and stage 4. Both stage 3 and stage 4 were ALWAYS the intended market. What they did not know is if stage 3 patients would respond better or at lower doses. They discovered that though stage 4 patients have a more impaired kidney, they responded equally, to similar dose levels as stage 3 patients. So they stated this in a news release and many think this is a NEW patient population that they discovered. What they found out was as long as the kidney still has some functionality, Rayaldee offers an equal benefit, regardless of impairment.
As far as Rayaldee for the general population, it would be fine and safe, but too expensive when otc would do the same.
There is the possibility that Rayaldee might be used in senior care facilities, and they are initiating cancer study.
Well, it did post a small gain last week, in a very weak market. Not sure when it will get to 18, but managing to eek out a small gain with the dow and nas off as much as they were is positive. The market as a whole appears to be out of steam, and opk does not trade in a vacuum, but out performing is a good sign. Now, if opk were to release some positive news, it might start a leg up move. Time will tell.
Though you might think opk is in a position to initiate a dividend, they really are not even close. Opko is still a start up, though a very advanced start up, with a couple late stage drugs, they are still burning through cash. So forget the PFE money, that is needed to advance the pipeline, fund phase studies, buy a small add on company, and is a hedge to doing any secondary offerings. Also it is a one time payment, not regular revenue or earnings. Dividends are paid out of FCF, not seed money, and that pfe deal gave opk a nice chunk of seed money.
Put another way, with the number of shares outstanding, a .05 dividend per quarter would be equal to all of last years revenue, and almost double opk's losses, inside of a .30 per share 2015 loss it would be .50. At .50 that is about 230m, wiping out the pfe money in short order. Opko would need do a secondary by late 2016 as they would be out of cash unless they get a drug approved.
Nice idea, maybe three years from now a .01-.02 dividend could happen, but not in 2015-2016 time frame.
We have taken it so far that we even know that the future sales price of Opk is a multiple of 18, lol, OPKO release some real news, Frost stop buying for a week so we can all babble about quiet periods, if they indeed exist or not.
Have a great weekend all.
I plan to study Pythagoras this weekend, why Pythagoras, well :
Pythagoras, the Greek mathematician who lived from 569-470 B.C., is said by many to be the originator of much of what we call numerology today. The actual origins of numerology predate Pythagoras, the most popular being the very old Hebrew Kabbalah.
but It still sucks.
U ALL know the facts, This has nearly no downside, upside will be a tad slow, but will get over 20 in 24 months, or a tad higher. maybe 22.
I mentioned mack on April 7, was at 12.15, did not buy OF COURSE, up to 13.30, in 9 days, hitting all time high today. Frustrating non buy, lol.
4B buy back is a very tiny percent of float about 2.4%. Though it will help, it is only about 250m share reduction, on over 10B shares.
These are all great points, UMM, otc vitamin d, or some sun exposure is enough for most people. Rayaldee is NOT SUITABLE FOR the masses, it is over the top. Rayaldee is for that 1-2% that cannot metabolize D, but that group is huge.
What I am posting next is old/but related news: In May 2010, we acquired worldwide rights to a novel heparin-derived oligosaccharide which has significant potential in treating asthma and COPD. Over 22 million people in the U.S. live with asthma, including nearly 6 million children. Additionally, there are more than 12 million people in the U.S. who have COPD.
This new news is an ADD on patent, but fits into the Nebulizer deal Oko did about a year ago. I did Email Opk to inform them arry has a phase 3 ready drug waiting a partner, thinking ( nebulizer ) could make arry's drug more potent. Oko does own a novel preclinical ( 8-10) year item, but could prove best in class.
Have yet to see a phase 1 announcement.
Still, Citigroup’s Keith Horowitz and Michael Cronin think Bank of American is worth buying. They explain why:
...but with the stock trading at just above TBV…we think the bar is low and [Bank of America] remains a tactical Buy for us based on our view that the Fed will be raising rates and this will be a preferred vehicle given asset sensitivity and screens cheap.
So basically bac might tread water until the fed raises rates, but accumulating on weakness until that happens, and it will happen, and based on that Citi feels bac is cheap.