Looks like Rayaldee is going to get approved as soon as third party manufacturer "cleans up" its act. The stock took a beating at open on what is actually good news long term.
He is probably ticked off over the screw up, and I think he will make the best of it and buy a couple of hundred thousand shares at today's fire sale. It is the least he can do!
I agree with you wholeheartedly. Frost's misstep gave us a great opportunity to buy on weakness. Shorts should take the opportunity and move on to greener pastures.
Rayaldee appears to be approved as soon as third party manufacturer cleans up its act. As this manufacturer is reportedly a large player in the pharma industry, I expect this will happen sooner rather than later. To me, the big positive for OPKO is their 4Kscore test that is gaining wider acceptance among urologists as a determiner of prostate cancer aggressiveness and the need for biopsies before or after the tests. Patients and insurance companies will demand this test before biopsies are done once the word gets out. My urologist, a top doc in a large practice with numerous offices, told me he just started using the test and he thinks it has a great future. I personally view today's dip as a great buying opportunity, in my case, to retake a considerable holding in OPKO.
Like I said, OPKO is a good long term play. FDA screw up was a gift that I couldn't anticipate. Oh well, sometimes you are good, and sometimes you get lucky. I expect OPKO earnings will take a hit for the next couple of quarters, but my faith in 4Kscore test made me willing to jump back in and wait. Good luck.
Very surprised that Frost did not pick up on this. Sometimes you just take a company on its reputation. In this case, it proved to be costly. Lesson learned.
If it is something significant, the delay could be longer. The least Frost should have done was disclose the problem especially since OPKO reportedly implied it would be fixed in a few months.
I like your thinking. Although I have owned a few stocks where things just kept getting worse, although I don't think OPKO falls into that category.
Evidently Frost's talk didn't make sellers happy enough to hold on. Considering all the studies and science involved in getting a drug approved, having a manufacturing facility's issues hold approval up has to tick investors off. It just shouldn't happen.
Hey, it will give OPKO longs something to look forward to. Think positive. Although it will have a negative effect on earnings for a couple of quarters most likely.
The FDA doesn't care who is short or long. They found problems in the facility and the wanted them corrected before they would grant approval. Makes sense to me.
Evidently, OPKO was wrong on that one. FDA requirements are strict but known, so this should have been avoided. Frost is not a newbie at this.
Initial press releases are negative, so I fully expect the stock will open down no matter what Frost says. However, once Rayaldee gets full approval, OPK will be back on track.
When I read the report, I saw where it said they agreed on labeling and would not require further tests to be conducted. I didn't see a statement specifically saying Rayaldee was approved. It seemed to say that the approval decision would come when manufacturing issues were resolved. To me Rayaldee approval is certain, but I guess that is what is causing the weakness.