What happens if opk is denied

All rights reserved. Charles St, Baltimore, MD On Nov. Just when investors were supposed to be seeing light at the end of the tunnel, the FDA decided to halt the approval of one of its biggest drugs, Rayaldee. But, what was the real issue? Opko Health said in a press release that the decision to halt the approval of Rayaldee has nothing to do with the drug in itself. Without a doubt, Opko Health expects Rayaldee to be blockbuster, with the company saying the drug will address an unmet market for stage 3 and stage 4 chronic kidney disease CKD.

OPK estimates that there are 20 million patients in this market in the U. Moreover, OPK expects that it will be a leader in this market.

Execs said during the conference call that there are currently no available products that can raise serum total hydroxyvitamin D 25D to recommended levels, something that Opko Health claims Rayaldee can do. In essence, expectations are that Rayaldee will be a billion-dollar drug. However, going by what a Motley Fool analyst said, the delay here would have meant that the potential market-leading position of Rayaldee is at risk.

The analyst explained that Amgen, Inc. By that logic, the delay here could mean that etelcalcetide reaches the market before Rayaldee. With the first-mover advantage in the healthcare space, etelcalcetide could take the leading position. The patient is typically tested during the gaze test with the patient sitting still. While a little spontaneous nystagmus is quite common in many normals, a small degree of nystagmus can be very significant.

Small amounts of nystagmus can help diagnose a peripheral vestibular disorder or in rare cases, a CNS disorder if the characteristics of the nystagmus are quite consistent with either a CNS or peripheral vestibular disorder. Very often, neither peripheral nor central nystagmus possess all their expected characteristics. Head Shake Test: With vision denied and the patient sitting, the patient shakes the head laterally at 2 Hz twice per second , for 30 seconds.

Nystagmus is observed after the shaking stops for 30 seconds at least. There may be a slight reversal of direction after the initial nystagmus dies away. Abnormal headshake nystagmus usually means peripheral vestibular disorder. Headshake nystagmus could also be a CNS sign, but this is rare. Richard Gans, Ph. Positional Nystagmus: This test looks for nystagmus with the patient lying with the head either to the right or left.

This can be accomplished in supine position with just the head turned either to the right or left, or by lying with the whole body to the right or left side. However, if there is nystagmus in either of these positions, then to rule out the neck being the cause, the patient needs to turn the whole body to the side thereby allowing the neck not to be strained and possibly causing the nystagmus.

If nystagmus is present, it is good to see whether visual fixation will suppress the nystagmus peripheral. This however, is somewhat misleading in that most cases of positional nystagmus at least in our office are peripheral. With the new understanding of horizontal canal BPPV, it is now realized that most cases of positional nystagmus are related to that disorder rather than a CNS disorder. Positional nystagmus would likely be of central origin if: nystagmus changes direction while in the same position there are exceptions , or, if nystagmus changes direction between right and left positions this, however, is also usually horizontal canal BPPV.

At this point in the discussion, it would be good to refer to the BPPV section. A lot of normals have a small degree of positional nystagmus. The choice whether to make an issue of this is somewhat complex. Caloric irrigations: This test looks for nystagmus vision denied after irrigating the ear with warm then cool air or water for one minute. For example, warm air at 44 degrees Centigrade is instilled into the right ear for 60 seconds. Then this is performed in the left ear. Similarly, cool air at 30 degrees Centigrade is utilized.

Shorter time periods can be used, if equivalent for all four irrigations. Again, the same amount of time must be used for all 4 irrigations. The examiner hopes for robust and equal responses on the right and left ears. Certain normal could have either hyperactive or hypoactive caloric response of any irrigation.

A hypoactive response is most often due to a small or occluded ear canal the bane of caloric testing. To solve the latter problem, rotational chair is a handy test.

There should be a suppression of the nystagmus with visual fixation if the disorder is peripheral. That is, with a right directional preponderance, there will still be nystagmus beating in the proper direction for the particular ear and temperature see above , but the total intensity of the nystagmus will be greater on the right side than on the left. A directional preponderance is most often seen in a severe peripheral vestibular disorder, because, if there is a strong right beating spontaneous nystagmus, this will often affect caloric results, causing a right directional preponderance.

However, in the absence of a strong spontaneous nystagmus, directional preponderance can be a CNS sign. That would be normal. With greater emphasis on this issue, small amounts of nystagmus becomes more significant if the nystagmus is of the peripheral type. Also, with the recent greater understanding of horizontal canal BPPV, positional nystagmus is less often considered possibly a central sign, especially if it follows the patterns seen in BPPV.

This is likely because of the underuse of peripheral nystagmus issues just mentioned.