CF update today

Discussing a medicine that stops the ravages of kidney failure is not the same as going to Amazon on line instead of Macy's by car. Nephrologists were put off by DeMarco's inside sales approach, and Frost decided enough is enough. But as I said, DeMarco is set for life. Frost made a mistake in hiring him, but cut his losses quickly and without remorse. I would never have hired DeMarco if I knew he thought telemarketing replaced voice and face contact in matters of life and death.
 






In office is always the best. But you need more than 35 Reps. Rayaldee is better this that. It's a future standard of care. The product will be huge and or the company could be bought for the right price. Enough said.
 






Think you are right on all that. Not sure if Rayaldee will be sold in the future, but it is a leading pharma for CKD. Short sellers take advantage of the incomplete info on café pharma to do damage to OPK shareholders, like they did yesterday. The short sellers (many of them hate Frost-- some have osted they wish he was dead) had a field day and it is good that management was alerted in a timely fashion Saturday (yes, Saturday) to the café pharma blurbs. Telemarketing a drug like Rayaldee is insane, and why DeMarco thought telemarketing had a promise shows his lack of understanding of how specialists (not simple MDs) view themselves. I don't have a problem with how specialist view themselves (they have a right to see themselves as special, as accomplished), but DeMarco should have known he was not ramping up aspirin sales. Frost cut the chord quickly, which is a sign of good management.
 






To the above poster, it may have been a good call but don't be so sure. Mostly what the inside team did was fax out PIs to as many offices as they could. Sure they never talked to the doctor, but they were marketing the brand name. For the people on here saying we need more marketing, the inside force was one of our best allies. Frost should have at least let them go a few more months to blast out more PIs and spread the word. That would help the brand name grow exponentially. With 35 reps it's growing at a snails pace.
 






It's not true that the only thing the inside sales team did was send out PI's. That was part of it but they also spoke directly to Dr.'s in offices where the field reps couldn't get in. Frost didn't seem to recognize the value of inside reps.
 






You are kidding yourself if you think clogging up fax machines will result in sales. What was achieved was annoying the offices where a high potential doc resideded with the telephone targets. Changing a treatment paradigm is hard work. You can't do that by reading a script.
 






The doc never hears about the clogged fax machine. That's a front office problem. The PI and marketing material comes through and is put on the docs desk. Then the doc is introduced to the product for the first time. So when the field calls on the office the product is already in his/her mind. The inside team has value because there are so few field reps.
 






many inside people got personal emails and even cells of prescribers. You have no clue . They worked their butts off too. Most outside people don't realize the abilities of the team. Other big pharm use them everyday to supplement the field. As they phase more Reps off or have small field force they have increased the hiring here. Many big marketing companies have been adding as part of their backbone. Knapper snd IMS use them. Obviously you are better in front of a doctor but if you see the efficacy and number of targets reached you will see the model work. It's water under the bridge at this point. You also need to send supplemental proof sources which was absent from Rayaldee launch . Hey Rayaldee is an amazing Drug that all the inside people enthusiastically marketed And at a similar pace to outside people in intensity. . Its the future shot standard of care I feel too. . The short sellers on Wall Street will loose cause the product is just beginning this journey. Frost will win and so will Opko but understand the abilities of those people.
 






The inside sales team had value. But if you remember back to the pre launch conference, the reph who was presenting made an interesting point. He said that Rayaldee would be a hard sell due to its effect being so low on the priority list for rephs. He said that vit D is 8th or 9th on the priority list for these docs, and it may be even lower. If the kdigo guidelines are updated to include Rayaldee as the preferred drug, or it becomes indicated for stage 5, things may change. Until then docs are going to place Rayaldee low down on their list of priorities. And if they do try it and patients can't get access, it will be forgotten. Question is does frost have the patience to wait this out or will he sell first?
 






Frost's expectations early on may be crazy but if he's the one that got rid of inside sales team/locked in lack of results---he made the right decision! Some of his tactics and expectations are nuts but the guy is smarter than most.
 






its hard to win the US Open with only a putter. That's all the Inside People had to send. The PI. When your Doctors go to a Speaker Dinner and are still confused and not Prescribimg after , then you need to get rid of the marketing Genius. If Phil is so smart then he should have reviewed the materials first. Even he would not prescribe it. Come on clown wake up. Its ok cause the next company that gets the product will do it justice.
 






Right On! if the information was presented correctly after reviewing, Dr Frost being detailed would Prescribe it! In droves. Proper Communication is the key with this drug.. Wrong with Vitamin D being the 8 th or 9 th on their list. Rayaldee needs to marketed as a better Vitamin D. . More effective delivery. It's the future standard of care. We see the underlying game changing results. So Dr Frost and Opko will do amazingly well. . Always a few bumps in each launch. I agree with above, Don't bad mouth people for trying with what they only have .
 






If Frost is so stupid, why does he keep buying the stock? He certainly does not appear senile and he is a cagy s-o-b. Ask the Ivax short sellers. The claim by some posters here that Vit D Rayaldee is low on the treatment list for neph's makes it such that if all other treatments for CKD do not work (and they don't) these nephs are going to have some bloody lawsuits from patients whose lawyers will want to know why Rayaldee, approved by the FDA, was not used while their clients are now on dialysis machines. Seems to me a lot of short sellers are posting here and not industry people. As I asked, if Frost is so stupid or delusional how did he become a billionaire and he keeps buying OPK shares?
 






If Frost is so stupid, why does he keep buying the stock? He certainly does not appear senile and he is a cagy s-o-b. Ask the Ivax short sellers. The claim by some posters here that Vit D Rayaldee is low on the treatment list for neph's makes it such that if all other treatments for CKD do not work (and they don't) these nephs are going to have some bloody lawsuits from patients whose lawyers will want to know why Rayaldee, approved by the FDA, was not used while their clients are now on dialysis machines. Seems to me a lot of short sellers are posting here and not industry people. As I asked, if Frost is so stupid or delusional how did he become a billionaire and he keeps buying OPK shares?
Your ignorance of bone and mineral metabolism disorders and chronic kidney disease is epic. Use of ergo and calitriol will never be listed as a primary cause of death, they are FDA approved drugs. Further, while interesting, there are no studies indicating Rayaldee offers a mortality benefit. Now go jump in a whilpool!
 


















A study in 1972, a comparison of the toxicity of Ergocalciferol and Cholecalciferol was done on Rhesus Monkeys. Oral doses of 50,000, 100,00 & 200,000 IU given demonstrated that Cholecalciferol was significantly more toxic than ergocalciferol. All animals given cholecalciferol developed hypercalcemia, died and had extensive soft tissue mineralization.

Hypercalcemia occurred in ergocalciferol supplemented monkeys, but the animals survived and comparable soft tissue mineralization was not evident after sacrifice. A unique feature of the lesion of cholecalciferol toxicity was the deposition of crystals resembling urates with an associated granulmatous reaction.

Moving forward, further studies have shown that known side effects caused by ergocalciferol and cholecalciferol administration include damage/impairment in the renal system. This may include polyuria, polydipsia, reversible azotemia, generalized vascular calcification, which may result to sever kidney damage or even death.

The prior available forms of nutritional vitamin D therapy for patients with CKD were ergocalciferol and cholecalciferol. Studies examining the bioequivalence of ergocalciferol and cholecalciferol are inconclusive, but suggest that ergocalciferol may be less potent.

There is also controversy as to the effectiveness of vitamin D supplementation with ergocalciferol and cholecalciferol in patients with CKD. One study showed that CKD patients treated with cholecalciferol experienced treatment resistance in increasing serum 25(OH)D levels to a pre-selected target level, while data from the CRIC study showed that increased vitamin D supplementation was associated with greater serum 25(OH)D levels, with a dose response relationship.

Patients with vitamin D resistance tend to have lower initial estimated glomerular filtration rate (eGFR), higher PTH, lower albumin, higher serum phosphate, and lower 25(OH)D levels.

In contrast, the modified release oral calcifediol produced gradual increases in both serum 25(OH)D and calcitriol without inducing FGF23 or CYP24A1. The CKD patients who received modified release oral calcifediol also had improved plasma PTH levels. A study of patients with CKD stages 2-4 with SHPT and vitamin D deficiency showed that treatment with 30, 60 or 90µg over 6 weeks of modified-release calcifediol increased serum 25(OH)D levels to >30ng/ml in more than 90% of subjects and reduced plasma PTH by >30% in more than 60% of subjects at dosages >60 µg/d.
 






A study in 1972, a comparison of the toxicity of Ergocalciferol and Cholecalciferol was done on Rhesus Monkeys. Oral doses of 50,000, 100,00 & 200,000 IU given demonstrated that Cholecalciferol was significantly more toxic than ergocalciferol. All animals given cholecalciferol developed hypercalcemia, died and had extensive soft tissue mineralization.

Hypercalcemia occurred in ergocalciferol supplemented monkeys, but the animals survived and comparable soft tissue mineralization was not evident after sacrifice. A unique feature of the lesion of cholecalciferol toxicity was the deposition of crystals resembling urates with an associated granulmatous reaction.

Moving forward, further studies have shown that known side effects caused by ergocalciferol and cholecalciferol administration include damage/impairment in the renal system. This may include polyuria, polydipsia, reversible azotemia, generalized vascular calcification, which may result to sever kidney damage or even death.

The prior available forms of nutritional vitamin D therapy for patients with CKD were ergocalciferol and cholecalciferol. Studies examining the bioequivalence of ergocalciferol and cholecalciferol are inconclusive, but suggest that ergocalciferol may be less potent.

There is also controversy as to the effectiveness of vitamin D supplementation with ergocalciferol and cholecalciferol in patients with CKD. One study showed that CKD patients treated with cholecalciferol experienced treatment resistance in increasing serum 25(OH)D levels to a pre-selected target level, while data from the CRIC study showed that increased vitamin D supplementation was associated with greater serum 25(OH)D levels, with a dose response relationship.

Patients with vitamin D resistance tend to have lower initial estimated glomerular filtration rate (eGFR), higher PTH, lower albumin, higher serum phosphate, and lower 25(OH)D levels.

In contrast, the modified release oral calcifediol produced gradual increases in both serum 25(OH)D and calcitriol without inducing FGF23 or CYP24A1. The CKD patients who received modified release oral calcifediol also had improved plasma PTH levels. A study of patients with CKD stages 2-4 with SHPT and vitamin D deficiency showed that treatment with 30, 60 or 90µg over 6 weeks of modified-release calcifediol increased serum 25(OH)D levels to >30ng/ml in more than 90% of subjects and reduced plasma PTH by >30% in more than 60% of subjects at dosages >60 µg/d.

Thanks for posting Dr. Frost.