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Neurocrine Biosciences Inc. Message Board

  • beachbarbob beachbarbob Jul 6, 2006 7:56 PM Flag

    Indiplon ====Hallucinations

    Hallucinations were observed in the higher doses of Indiplon. This is one of several reasons why the MR 20Mg dose was pulled from the NDA package and replaced with the 15Mg version. One has to think, is the 15Mg dose subject to causing Hallucinations???. Sleep maintenance is 90% of the insomnia market and without this version, Indiplon is not competitive to Tylenol-PM, longterm p3 trial data is 18 months away.

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    • So I think we can all agree that Pfizer knew what the data was prior to the FDA submission. They not only encouraged NBIX to go to the FDA w/ the data that they had, but also requested an expidited review of the data. They obviously felt that the data was sufficient to get an approval, or at least an approvable letter, as did the analyst community (likely based on PFE's confidence in the approval). This, to me, at least in part negates the short argument that "obviously Pfizer knew what they were doing" when they dumped NBIX. If Pfizer knew what they were doing, they never would've requested a fast-track review knowing that there was a possibility that the FDA may not have the opportunity to review all pertinent 15mg clinical trial data before rendering a decision, so claiming Pfizer has vast expertise regarding what the FDA is looking for to approve a drug doesn't hold water with me. Secondly, in simply reading the non-approvable letter, per what Lyons stated in the CC, it's not immediately clear what data was and was not reviewed prior to the 15mg decision being rendered. He stated that he believed specific trial data was not reviewed prior to the decision, hence it is hard to tell exactly what additional information/studies the FDA may be looking for, or if the additional 15mg data they were looking for has already been submitted, but not yet reviewed. One possibility is that Pfizer felt in reading the non-approvable letter that there would be more in-depth trials than what NBIX felt would be needed after they reviewed all of the data, which led to tension between the companies.

      NBIX obviously felt that they hadn't submitted all of the data necessary for a full review, hence the reason they kept submitting data which may or may not have been looked at (and according to NBIX, they believe it wasn't all looked at or taken into consideration prior to the FDA ruling).

      The FDA gives Indiplon 15mg MR a non-approvable letter, while giving the 5 and 10mg an approvable. This, IMO, speaks to efficacy of the drug itself. To me, this leaves two unresolved issues: safety and/or lack of sufficient data regarding the 15mg dosage. Simply reasoning through this provides those two possibilities for the non-approvable letter for the 15mg dose.

      It is a well known fact that NBIX submitted some of the 15mg clinical trial data late in the review process, and I think it's safe to assume that more likley than not, it was not reviewed and hence not taken into consideration by the FDA prior to the ruling on the 15mg. This is where things get cloudy for me, and maybe pin can answer this question for me: IF the FDA didn't review all of the 15mg data prior to issuing the non-approvable letter, will they go back and review the trial data submitted but not reviewed (prior to the non-approvable letter being issued) prior to the meeting on the 15mg dose, and go from there, or will they go into the meeting using the only the data that they reviewed prior to the non-approvable letter being issued, tell NBIX what "additional" information they may need, and leave it up to NBIX if to determine if the 15mg clinical data that they submitted in February would suffice in answering the remaining questions that they had after review of the initial 15mg data?

      I think this is a huge question that needs to be answered as an investor in NBIX, and knowing that at least in part, the timeframe for possible approval of the 15mg dose will at least in part impact not only the market share 15mg can capture, but also ascertain the short-term viability of the company.

      If I were a betting man, I would guess that the FDA will require a 3 month non-crossover study of the effect of 15mg on elderly patients. I have thought, and still think that this is the most likely scenario. This leads me to believe that we're looking at probably 15-18 months before we see MR hit the shelves (assuming that the results don't bring any unexpected sur

    • thanks

    • =====Sleep is a tough field to set up a sales force. Make no mistake, PFE pulling out is huge. They have several divisions that detail primary care, another one that details neurologists. I don't know if they detail pulmonary much.

      Well yes especially considering one of their new major products is exubera. This would be handled by their uro/respiratory division. Indiplon would've been marketed primarily by the neuroscience division.

      It's good to see someone with an actual understanding of how the sales force works. After a couple of weeks of seeing morons and idiots post that drugs will sell themselves (*cough* pinvestment) and their fellow idiots recommending these posts, I was starting to wonder why none of the major pharmas are hiring these geniuses from the NBIX board to help them slash budget by getting rid of the entire sales forces--hey the drugs sell themselves anyway right?

    • "Exactly what straddle are you playing? TIA "

      On the put side, I have a combination of Aug 7 1/2, Nov 7 1/2 and Aug 10. On the call side I have Nov 10 and Nov 12 1/2. And I still have a bunch of worthless Jul 22 1/2 and Aug 22 1/2 from the first straddle.

      I have roughly 4 put for every call. It is a more or less neutral straddle in that we are so close to cash value, the downside for the stock may be at 3.00 but the upside can easily be 20. And the straddle will lose may be about 50% of the money if we have a FDA meeting before end of July (as our CEO said) and stock don't move at all (any chance of that??). And double my money if it drop to 6 or rally to 20. You can construct any combination of straddle you want and figure out the end point and the return for your most like scenario. My most likely scenario is that we will have a 9-12 months trial and won't hear from FDA until 22 months or so from now. And the stock price will drop to the cash value (5-6).

      When I set up the first straddle, I was as bullish as everyone here based on our CEO comment that "FDA don't have time to review all the data" and set up a 1.8 call to 1 put straddle around 20. I was wrong but at least I make 75% of money instead of lossing all of them. Good luck on your bet (and I think "bet" is appropriate here unless you have an inside line to FDA and know exactly what is going to happen), long or short. Get some protection one way or the other...

    • Pin, I think we differ on the outlook. With PFE pull out, I think we are pretty know that there will be a new trial and a long one at that. Unless, of course, the PFE people are all idiot. But at least they are the idiot who have access to the non-approval letter, all the trial data before, and NBIX response to FDA. I see 50/50 chance that we need to re-run safety and elerly trial with 15 mg and we may be looking at a 9 month to 12 months trial. I don't think anyone of us know for sure what would happen. Hence my objection to be 100% bullishness without understanding the pitfall that if things do not break the bull's way.

      As far as the money go, with a 9 months to 12 months trial, and launching 5mg and 10mg at the same time, I don't think NBIX has enough money for 1 1/2 year (we can all run through our number for their potential cost). Remember they need to ram up the sales but the expense are incurred immediately. So you cannot count on 100M or whatever the project for 5mg and 10mg sales. Also understood that those projection based on PFE doing the marketing and has the marketing muscle vs now you are talking about a new sales force from NBIX doing that. If IR is on the market for 6-8 months from now as you expected, the money may not roll in and make the effort profit neutral unitl a year from now and keep burning money in the mean time.

      I wouldn't worry about the ABRX thing. If anyone invest for any length of time, we will make wrong call. I had made plenty of wrong call myself. As long as the right one make up for the wrong one, we are still in the game. The point though is that investment is a probability game. None of the things are certain. You bet on more if things are favorable and less if things are not favorable. The problem I have is that the discussion for NBIX is almost as if approval is a foregone conclusion and it will happen in a few months. And everyone is betting their fortune accordingly.


      My view is that we are all depend on FDA now. If you are long and like the science for the long term, you has a possibility to buy it cheaper if the ruling is against NBIX. If the ruling is favorable to them, you can buy more later... There is no real need to go "all in" with so much unknown and invite a margin call. At a minimum, there is going to be another approvable, non-approval, and approved game of chance down the road that we can all play again. Long or short, it is not something that is 100% sure.

    • Are you attempting to say that you're going to dream about me tonight? That's a little weird dude, but if that's your thing, who am I to stop you. It's easier to dream with a picture in mind, you can use this one.

      http://www.joe-ks.com/archives_feb2003/WannaBuyAVowel.jpg

      It looks nothing like me, but hey, you don't know that.

      NoBuddy
      PS Could you say something useful? Otherwise I'll have to put you on the boorder, j2, & lucifer list.

    • Yes, I am self promoting. I think it's because I have a superiority complex. It would be easier for me to address my complex if people like you didn't exist. But if ifs and buts were candy and nuts we'd all have a merry Christmas right?

      As for requiring medication, at least I know where I stand, do you?

      Proof of need for medication is posted below. It should be noted that these vacillations occurred over a two week period.

      Now if you promise to be quiet, I'll try to feel less superior.

      NoBuddy


      ==================================
      smoke. fire .kaboom. adios
      by: rexmundiz 06/23/06 08:11 am
      Msg: 24263 of 29480

      just sell it and buy back @$4
      ==================================

      ==================================
      WILL CLOSE BELOW A BUCK TODAY
      by: rexmundiz
      Long-Term Sentiment: Strong Sell 06/23/06 08:29 am
      Msg: 24323 of 29480

      ill buy @ 55 cent
      ==================================


      ==================================
      going back to $20
      by: rexmundiz 06/26/06 12:53 pm
      Msg: 26719 of 29480

      <EOM>
      ==================================


      ==================================
      Hold your shares dummies
      by: rexmundiz
      Long-Term Sentiment: Strong Buy 06/26/06 01:02 pm
      Msg: 26727 of 29480

      its a no brainer
      ==================================


      ==================================
      MANIPULATION
      by: rexmundiz 06/26/06 01:57 pm
      Msg: 26776 of 29480

      $5 pricetarget ? i can not believe it. talk about stupidity. its just amazing
      ==================================


      ==================================
      Re: NBIX WAY OVERSOLD, $15 OR HIGHER SOO
      by: rexmundiz
      Long-Term Sentiment: Strong Buy 06/26/06 04:29 pm
      Msg: 26866 of 29480

      $30 would not surprise me
      ==================================


      ==================================
      Frankly
      by: rexmundiz 06/26/06 06:02 pm
      Msg: 26904 of 29480

      i dont see much future for this stock. i consider it a pure technical play right now. i have a hard time seeing what should drive it in the longer term. i believe a fast buy out will be the best for all involved.
      ==================================


      ==================================
      shorts had trouble this morning
      by: rexmundiz 06/27/06 01:09 pm
      Msg: 27185 of 29480

      but now they are happy. but frankly im even more happy to be able to add to my position.
      ==================================


      ==================================
      pridictions
      by: rexmundiz 06/29/06 09:52 am
      Msg: 27832 of 29480

      i believe it all end in red today. then a slow slide down to november
      ==================================


      ==================================
      next week prediction
      by: rexmundiz 06/30/06 12:13 pm
      Msg: 28186 of 29480

      annual eeting could give the stock a boost. i believe it could go a bit higher, technicaly its oversold, also out of the historical tradingrange, a little positive, and it will jump. imo
      ==================================


      ==================================
      SELL SELL SELL THE STOCK IS A JOKE
      by: rexmundiz
      Long-Term Sentiment: Strong Sell 07/07/06 03:46 pm
      Msg: 29468 of 29480

      and so is this pathetic board
      ==================================

    • i didn't see anything you posted that made any sense of invalidated what I did

      do you realize that you are raving at someone about something you know nothing about

      its like you are trying to tell me that my ID is not "pinvestment" - as before continue with it as long as you like - you can't change history

      i bought on the first trading day in the middle of the day after the BK announcement

      go ahead - tell me i am wrong

    • =====Subj: thaumaturgist-keep trying
      By: pinvestment
      Date: 07/07/06 01:42 pm

      you can't change history - but you can keep trying - why don't you try to prove anything you said - with one fact

      just prove with one fact that I am wrong on what i have said about ABRXQ - i know you can't

      so feel free to keep plugging away

      *****

      So let me get this straight:

      I posted your exact post where you claim DIPS financing is the "linchpin" to let ABRX go back to 3, it never saw 3 again.

      After you claimed
      1. you didn't buy ABRX till 0.60
      2. you bought ABRX right after BK declaration

      I posted your exact post, 2 days after BK, when the price was still $2 and you're touting it as worth $8. Proving at least (1) or (2) was a lie, probably both.


      Now you're just trying to divert attention with your typical BS as if none of these posts happened. "just prove with one fact that I am wrong" bla bla bla.

      Go take some finance classes rookie, you're in above your head here.

    • you can't change history - but you can keep trying - why don't you try to prove anything you said - with one fact

      just prove with one fact that I am wrong on what i have said about ABRXQ - i know you can't

      so feel free to keep plugging away

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