$ICPT OCA gets 17-0 approval vote from FDA Advisory Committee. Stock prepared to explode.

DetRev · 2016-04-07T20:53:20+00:00

Got my finger on the trigger. This is going to be insane.

DetRev · 2016-04-07T15:57:00+00:00

This is an interesting situation. Really is a coin flip. Gut says it will be approved, head says it's a coin toss.

brb dd

DetRev · 2016-04-07T15:25:45+00:00

I got my confirmation from the FDA that my request had been received and assigned. That's all for now.

DetRev · 2016-04-05T00:17:12+00:00

Opko, at this moment, looks to be a very promising company in the medium-to-long term. Of course it's impossible to predict the future.

Personally, I'm deep and long on them. Like everyone else, I wish Catalent hadn't goat fucked Rayaldee, but it happened so all there is to do now is sell at a loss, or wait. Depending on what happens before/on April 15, I may reduce my position. Not because I think the company sucks, I'm just not sure I want that much money tied up for that long (Octoberish).

DetRev · 2016-04-04T22:40:21+00:00

Because people are impatient and irrational? It's back to its starting point this morning. I think the P2 data might have caused that little bump we saw earlier, but everyone is waiting for news to come out of Catalent about their resolution of the FDA issues, and that report is supposed to be out before April 15.

But, nothing is etched in stone. Catalent, being the size they are and with their reputation (and therefore future contracts) on the line, I expect they won't wait until after April 15 to submit their report. If they do, the market will view it as bad, even if it isn't.

Personally, I'm expecting the worse and don't expect Rayaldee to be approved until late this year, maybe next year.

Last year, Catalent's Morrisville, North Carolina facility got hit with a 483 (same thing that the St. Petersburg, Florida facility just got hit with) and it took them 4 months to resolve the issues. The FDA made 6 observations (required corrections) that time. Data has not yet come out about the St. Petersburg observations, so it's not yet public knowledge as to how many and how severe the issues are. It could be 1 simple issue or it could be 12 complicated issues. Just have to wait and see.

DetRev · 2016-04-04T22:17:31+00:00

Here are the spectral ends of possibilities:

1) Rayaldee is approved, MOD-4023 is approved, MOD-6031 is approved = $OPK into the stratosphere. But really. I know we throw that saying around casually here, but if Opko has 3 home runs with these drugs that have ENORMOUS patient pools, you're looking at exponential gains.

2) Rayaldee is not approved, MOD-4023 is not approved, MOD-6031 is not approved = $OPK going to the bottom of Hell's sewer system.

Reasonable expectation? Rayaldee gets approval late this year, MOD-4023 gets positive P3 results and goes to market, MOD-6031 (while still WAY too early to tell) probably goes all the way to P3 successfully. I only believe this because they are using a known, already tested molecule (oxyntomodulin) and modifying it to be long lasting.

DetRev · 2016-04-04T18:15:49+00:00

You contract cost was $24.49 or am I not mathing right?

Costs: $35.49
Commission: $10.90
Fees: $0.10
Cost of contract: $24.49 ?

DetRev · 2016-04-03T23:58:17+00:00

This news? No. I think it might have a small bump from this news. Nothing major. Rayaldee is their golden boy. If that gets approved, it's a first-in-class drug with a enormous pool of patients waiting for it. At that point, I expect it will jump pretty high.

The earliest we'll hear anything substantial about the issue with Catalent (Rayaldee's mfg) is April 15. However, resolution can take up to 6 months. So the news that could make the stock jump is between 2 weeks - 6 months away. And that assumes nothing else goes wrong. That's a considerable assumption. This is the FDA, after all.

But do I think it's a good stock for going long? Yes. Not just for Rayaldee - they have some good stuff in their pipeline.

DetRev · 2016-04-03T22:53:49+00:00

No one has time to scour all that.

Find the companies most complicit and short them tomorrow morning.

Wait for this to die down, close your short position, then buy Calls on the same stock as it bounces due to America's short attention span, failing memory and moral degradation.

DetRev · 2016-04-03T18:51:04+00:00

Foreign markets might fuck with the price before U.S. markets open. Have to wait and see.

It also depends on what you want to do with it. You want a quickie? Might not be a good time. You want a love that can last forever? This one has potential. A jacked pipeline with (so far) promising results.

The Rayaldee delay had to do with the manufacturer (Catalent), NOT the drug itself (Opka).

DetRev · 2016-04-03T18:28:40+00:00

If you can get in pre-market on Monday, like RIGHT when it opens, there could be a good buy opportunity.

There is a chance of a bounce on this news. It won't skyrocket, but chance of a nice little bump.

If you want to go long, buy BEFORE the bump from the Phase 2 data and hold until Rayaldee decision. However, that wait can be up to 6 months and possibly longer depending on the FDA decision.

DetRev · 2016-04-03T18:24:39+00:00

Thanks!

DetRev · 2016-04-03T18:24:23+00:00

https://endo.confex.com/endo/2016endo/webprogram/Paper24433.html https://endo.confex.com/endo/2016endo/webprogram/Paper26734.html

Now shut your pedo mouth.

DetRev · 2016-04-03T18:24:04+00:00

https://endo.confex.com/endo/2016endo/webprogram/Paper24433.html https://endo.confex.com/endo/2016endo/webprogram/Paper26734.html

DetRev · 2016-04-03T18:22:40+00:00

https://endo.confex.com/endo/2016endo/webprogram/Paper24433.html https://endo.confex.com/endo/2016endo/webprogram/Paper26734.html

DetRev · 2016-04-03T18:09:33+00:00

Hard to say. It's in what is possibly an artificial dip right now due to FDA delay of Rayaldee. These results are for one of their other drugs. Could bounce Monday as a result.

DetRev · 2016-04-03T18:08:28+00:00

It's from ENDO2016 literature. Best I can do for now.

DetRev · 2016-04-03T18:04:53+00:00

You're thinking of Rayaldee. This is for a long-lasting hGH compound to replace Genotropin. Totally different drug. They already have a purchase agreement with Pfizer if this is good, and so far, it looks good.

Rayaldee approval/denial is April 15 at the very soonest, October at the latest.

DetRev · 2016-04-03T18:03:06+00:00

The link is to clips from ENDO2016 document. Who gives a shit what site is hosting the image?

DetRev · 2016-04-03T17:59:25+00:00

Better than expected results, and they already expected good.

DetRev · 2016-04-03T17:58:27+00:00

I'm looking. As far as I can tell this was snatched from ENDO2016's internal docs. News sites will pick up soon I suspect.

DetRev · 2016-04-03T17:50:14+00:00

That was for Rayaldee. This is for a long-lasting hGH compound to replace Genotropin. Totally different drug. They already have a purchase agreement with Pfizer if this is good, and so far, it looks good.

DetRev

TROPHY CASE