Honest discussion of risks with Rayaldee

I am not concerned about Rayaldee working and doctors using it. I am not expecting 10B in sales but I do think its a great advancement for those with CKD. Many people I think don't understand it because they don't realize how debilitating it is what what CKD eventually does to the body. Bone disease, heart attacks, this is what people have real issue with and die from when they have CKD. Rayaldee can help millions with these and lower their risk, let them live longer and stronger. Why the hell wouldn't you want to be on Rayaldee if you have CKD, thats the real question.

First off - thank you AWalt for posting a legitimate question.  I am very long OPK with a lot of shares, but I almost want to hear the negative side of the OPK argument more than the positive side.  After all, we don't have to worry about the positive - we would all make money.  It is the negative, and the doubts, that we should all be very conversant in.

The only thing I have to add to what Burn says is that I would imagine Dr.'s are not actively out there reading all the literature they can on Rayaldee.  We would hope all Drs are very up to date on the latest progress in their field, but hey, they might get a little busy helping patients.  It is OPK's job to educate these Drs and when the sales force comes out, I am hoping that is exactly what they will do.  Doctors are busy and the drug just got approved, I think that is what can be read out of these numbers.

 It would be nice to see one of those commercials that say "ASK YOUR PHYSICIAN TODAY " . Problem solved . Its that simple !!!!

Awalt. IF the FDA approved Rayaldee, WHICH they did, there are no questions that can be raised about the trial design at this point. THAT is WHAT the FDA DOES, and they do toss drugs based on design, incomplete data, and many other things the company should have seen. The FDA APPROVES the trial design before a study is EVER started, so it is always a head scratcher when a company implements it wrong.

The FDA APPROVAL says the design MEET it's goal, the DRUG works for SHPT as approved, this data goes in the insert.

AS far as Palmetto. I wrote at length as others to figure out what is up with that. They YAKED a TON about the study, and the design, and old vs new data, etc. etc. IF you read their summary, they state in spite of ALL THEIR BS haranguing that the results, after listening to all the arguments and discussions put forth, WERE indeed VALID. That word, term, VALID is a BIG DEAL. IT is a clinical testing term that means the TEST MEASURES what THE company CLAIMS it measures. SO fact is, they whined and whined, then retracted ALL OF their whine as soon as they used the TERM CLINICALLY VALID. THEY would have not WHINED if opko said EVERY guy with a PSA over 3 GETS a BIOPSY. DANG, the test is a decision making tool, to prevent those, not reflex into one. To FIT their criteria, opko also would have had to state a cut off, use 4k at X psa, DO not USE 4k below X. OPKO did NOT RESTRICT the Drs. use and they INITIALLY FOUND that as a HAMMER, then backed off in their summary.

CLINICAL UTILITY, was their out phrase. Their logic was that if a psa is above 3, and you do not do a biopsy based on the 4k score, a % of cancers will be missed. THAT is WHAT they were stating with clinical utility. SOME patents COULD be harmed if no biopsy. WE ALL GET THAT. THING is, OPKO'S and the DRS. who wrote letters felt FEW are MISSED and at 50% fewer biopsies, more men are helped than hurt. I think 4k catches 85-90% of aggressive cancers, which is about on par with a first biopsy. PALMETTOS stance was missing that 10% was too high. BIOPSIES miss that much TOO, or more on first biopsy, but regardless, they used that as the BIGGEST reason to say no coverage. THE phase clinical utility is about that, and in their summary. IF you REREAD it, you will see they said " VALID " measures aggressive cancer, but does not meet " THEIR CONCEPT " of clinical utility, ie., as valid as it was, it CAN still lead to non treatment ( BIOPSY ) in a few.

OPKO did a good job on the study, if they added another marker or two, then maybe they can lower the miss rate to 5%, from 10, but that is not going to happen. They are one player, they had to EAT DOG STUFF once the study design was EXPLAINED to THEM better, so their rejecting on another ground, umm, not shocked, but puzzled. I think they are wrong, but my opinion is worth a double DOSE of DOGGY STFF, so there is that.

I get it knowing why they rejected does not help, it changes nothing, the opinion at Palmetto will stand unless severals others come on board. They made it harder cause for others to approve that is like stating " Palmetto you had trouble with the design, and then said it was valid, and now you are saying utility, and guess what, you are wrong on that too. "  SO it would be a back hand to one of their buds, but I still think that COULD, umm, SHOULD happen.  PALMETTO is wrong on their utility interpretation, but THAT is JMHO.

JUST HAD a tiny light bulb go off, umm, maybe. The question was POSED by a yahoo short and I had NO answer. THE question was if 4k SAVES so much money in biopsies and Palmetto pays for biopsies why would they NOT COVER 4k? THEY WILL save MONEY!! OF course he likely said LOUSY test, yada yada.

DANG, he had me, lost for words, lol, ( dry humor ).

I reread their SUMMARY AGAIN, for the 7th-8th time, cause I am a slow reader, and I kept getting to the part about DRS. reflexing into 4k, Drs. REFLEXING into 4k, yep, there it was. BINGO, LIGHT FLASHES. THE GP that OPKO is concentrating on now, who order most psa tests are REFLEXING into 4k. THINK about that. PALMETTO also says there is NO PSA score listed that DRS. cannot reflex into. THINK on that.

So the BOTTOM line is PALMETTO realized there are 30m PSA tests done, most by the GP, not urologists, AND THEY ARE REFLEXING 4k into that 30m PSA number. TEAMING psa and 4k on blood draws. SO WHERE is the savings from less BIOPSIES, out the window, WAY OUT the window if the GP is REFLEXING 4k, as OPKO said, and PALMETTO said.

NOW the Dr. knows, or should know 4k is predictive, so a vital valid part to keep in a patients history, so yah, reflex into it on an initial LOW psa and file the info, thanks, good idea Dr. Palmetto, IF WE FOLLOW the money KNOWS that as a REFLEX test to PSA, regardless of PSA, they SAVE NOTHING. WELL, yah, there are 1m biopsies, many unneeded, but it is a cash win to pay for those and not pay for 4k if it continues to build momentum as a reflex on all psa tests. BINGO, that is their money angle.

So yah, yahoo board is a waste, but the idiot made me think, yah, why not if it saves them $. I might be wrong, but PALMETTO PUTS there DISLIKE of 4k as a reflex thingy right in that SUMMARY. I will BET ANYTHING that is it.

See, it's always about the money!

A new Marketing plan for Bio and 4K😂

Buy one get 2nd half off.

So if the Dr. Orders a PSA and at the same time orders 4Kscore. PSA at regular price. You then get the 4K at half price. But you have to have big margins on the 4K to do this. We all are just arguing of the price.

This will drive the 4K and drive doctors to use Bio.

I know this type of promotion is below Doctors. We all know they're not there to sell things.

It's late at night and see what you people are doing to me. For the younger members your nights will come.

You have sunken the nail with one hit!