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Arena Pharmaceuticals, Inc. Message Board

  • iago4466 iago4466 Feb 9, 2013 12:17 PM Flag

    DEA: 30 or 45 days

    Serious discussion point for the longs who do DD. Last December, there were some very thorough posts and discussions about the DEA process, and the general consensus seemed to be that the post-comments review period (the one we are now in) had a maximum length of 30 days as per DEA regulations. That would take it to Mon Feb 18 I think (and Feb 18 is a holiday, so in practice it could end on Fri Feb 15, the last working day before the end of the 30 days). But, recently, there have been references on the board to the maximum allowed length actually being 45 days, which could drag the process out until early March. I do recall SOME discussion of the 45-day period back in December, but I could never verify it was correct. Does anyone know for sure just how long the DEA could take, under the law? There's now quite a large $9 Call options position building up for the Feb 15 OpEx, which I assume is based on the assumption that the DEA has 30 days and would sign-off by next Friday (Feb 15). I don't do options, but the point is still valid. Anyone truly know whether DEA can drag it out beyond 30 days?

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    • Not really sure what is going on with DEA. One thing Im sure of though is that every timeline in place for ARNA seems to happen at the very longest/maximum day! So dont get too excited if it once again does not happen on the 30th day or Feb 18th. One thing I know for sure is that it will happen this year... 2013! This is our year!

      Sentiment: Hold

    • Thanks to Tiger_Josef for his thorough and clear explanation, posted this morning. Anyone who missed it should take a look. In summary, it does look like has DEA has 45 days to respond and, by precedent, tends to use most of that period (longer in one of the 4 cases Tiger dug up).

      Tiger, two follow-up questions if I may?

      1) For the four cases you reported on, did any of them involve a significant number of FR comments that DEA had to respond to? As we all know, the Belviq dossier contains nearly 70 comments from "the public".

      2) All of the four cases had the final post-review 30-day legal period applied before the ruling became final. As we know, Eisai has asked for that period to be waived. The December discussions on this board revealed several recent examples of where DEA had indeed waived that 3--day period, leading to optimism the same would apply to Belviq. But as all four cases you cited did involved that 30-day period, is our optimism justified? Are we looking at early April for the launch?

      Given how these threads and their nested replies can get convoluted, and lost in the spam, maybe a new thread specific to this point might be justified? Compared to some of the stuff discussed on this board, to me this one does seem pretty fundamental.

      • 2 Replies to iago4466
      • Iago,

        On Vimpat (Lacosamide) - Schedule CV there was two comments and there was NO formal request to waive the 30 Day Lag to effective period.

        On Lusedra (Fospropofol) - Schedule CIV there was two comments and there was NO formal request to waive the 30 Day Lag to effective period.

        Note: I believe there was more comments than just two for the above two drugs, the comments are not showing up in the search at the DEA website, may be they were discarded by the DEA...

        Given the above, I believe that there is a good chance that the 30 Day lag to effective date will be waived by the DEA for Lorcaserin.

        Sentiment: Buy

      • Iago,

        All dates below are the actual dates for each of the four drugs cited and all were after the 2006 Ruling that required a 30 Day Lag to effective dates.

        Nucynta was a special case with Final Scheduling that took 63 Days due to FDA Granting the Waiver to PAS otherwise would have taken 40 Days. Nucynta is a Schedule II; therefore, I believe the 30 day to effective date waiver would not have been possible.

        DEA Schedule II Prop Rule | 2/17/2009
        DEA End of Comment Period | 3/20/2009
        FDA Grants Waiver for PAS | 4/29/2009 | 40 Days
        DEA Final Rule - Schedule II | 5/22/2009 | 63 Days
        Authorized to Market | 6/22/2009

        Similarly Vyvanse - is a Schedule CII ; therefore, I believe the 30 day to effective date waiver would not have been possible.
        NPRM | 2/22/2007 |
        End of Comment Period | 3/26/2007
        Final Rule | 5/3/2007 | 38.00 Days
        Eff Date | 6/4/2007 | 32.00 Days

        The remaining two Drugs Vimpat and Lusedra are both Schedule CV and CIV respectively; however, I do not know how many comments each had and whether the applicant requested for the 30 Day Lag to effective date waiver or not. Both the Number of Comments and whether the 30 Day waiver was requested would have to be researched for Vimpat and Lusedra in order to answer your questions appropriately.

        Vimpat - | Schedule CV
        NPRM | 3/10/2009
        End of Comment Period | 4/9/2009
        Final Rule | 5/21/2009 | 42.00 Days
        Eff Date | 6/22/2009 | 32.00 Days

        Lusedra - | Schedule CIV
        NPRM | 7/23/2009
        End of Comment Period | 8/24/2009
        Final Rule | 10/6/2009 | 43.00 Days
        Eff Date | 11/5/2009 | 30.00 Days

        Sentiment: Buy

    • I’m not overly concerned when the DEA will issue the final scheduling but the worse case scenario would be April 23rd based on Tigers model 2 projections, which is fine with me. As I don’t trade options, have a core holding and trade in the shadow of the HFs on technical analysis alone just to cover lunch money and some light entertainment.

      Iago in my opinion to date everything that can go wrong has gone wrong in relation to our timeline expectations, so for that reason I’m not holding out much hope that the DEA will come to our rescue and issue a scheduling ahead of the due date.

      A few more months in the overall scheme of things is not an awful lot to ask - from an investment point of view. The encouraging aspects now for an investor is institutional ownership increasing once again while we don’t have a final figure it would appear it’s on the up.

      Patience is the key.

      Sentiment: Strong Buy

    • BELVIQ Launch Comparison to existing NCE products using a presentation entitled Industry Perspective on Scheduling Process by FDLI.org
      =======================
      MOD 1) BELVIQ timelines using Vyvanse Model | Model Date
      Publication in FR | 12/19/2012
      FR Comment Period | 1/20/2013
      Final Scheduling | 2/27/2013 | 38 Days
      Lag to Effective Date | 3/31/2013
      =======================
      MOD 2) BELVIQ timelines using Nucynta Model | Model Date
      Publication in FR | 12/19/2012
      FR Comment Period | 1/18/2013
      Final Scheduling | 3/22/2013 | 63 Days
      Lag to Effective Date | 4/23/2013
      =======================
      MOD 3) BELVIQ timelines using Vimpat Model | Model Date
      Publication in FR | 12/19/2012
      FR Comment Period | 1/18/2013
      Final Scheduling | 3/1/2013 | 42 Days
      Lag to Effective Date | 4/2/2013
      =======================
      MOD 4) BELVIQ timelines using Lusedra Model | Model Date
      Publication in FR | 12/19/2012
      FR Comment Period | 1/20/2013
      Final Scheduling | 3/4/2013 | 43 Days
      Lag to Effective Date | 4/3/2013
      =======================

      With the waiver of the 30 day lag to effective date and by comparison to Vyvanse, Vimpat and Lusedra excluding Nucynta; the expected Final Scheduling dates would be between February 27 thru March 04, 2013

      Sentiment: Buy

      • 2 Replies to tiger_josef
      • Tiger -

        All of these drugs were at the same time. Does anyone know if any other drugs are currently under review.

        My point is that the limited resources could (and should) be directed toward the one durg under review.

        Second, as one poster pointed out, it could be 15 to 45 days. OP asked what was the max., and we can infer (even without looking at the legaleze of the regs.) to see 45 days is the max. - there are many examples of 45 days.

        I am not a scientist, but as a layman, there are very few drugs that ever get scheduled; also, many are not common drugs (many came from the early days of DEA/FDA guidance).

        Tiger - I am using the other Scehdule IV drugs (both since DEA decided to be more efficient and transparent) in 2005. Today is Day 24. Egozabine was Day 24 and Zopiclone was Day 19.

        Some may think I am pumping, but you may want to consider earlier than 30 days (i.e. this week).

        2M shares in 2 hours. I am waiting for the next 10-30 million blip and we should see one this week.

        We are overdue!

        GL

        chrisanja $8.79

      • Tiger... did you check the timeline from the close of the FR Comment period to Final Scheduling with respect to the number of comments the DEA received for the four examples you site? For Belviq, 69 comments were received by the DEA-- do you know how that compares with other drugs (e.g. Nucynta, which took 63 days)?

    • Overcalculating calendars for an option strategy puts you in with the popular thinking crowd and therefor is a pretty sure way to lose.
      If you have a good mind and also are a little "unusual" and you march to a different beat, and you talk about things coming out of left field that annoys the average investor....
      well, you are the one that makes the option bets that others laugh at,
      and that is where the money is,
      imo
      NOT THAT ANYBODY ASKED THAT QUESTION, ha-ha

      Sentiment: Strong Buy

    • From jan 18th it can take between 15 to 45 days.After that is can take an
      additional 30 days unless Eisai gets a waiver.So if we go the entire 45 days
      and Eisai gets a waiver you are looking at march 4- or 5th

    • First I do NOT know for sure. My wife and I both work for the Government --totally different departments / sections of the executive branch -- I don't know anything more than any of you but I do know that the Government process in general is terribly slow and there are very few areas where there are hard legally bound time lines which WILL be kept. There are far more informal ones which are generally kept but that depends on importance, current workload, complexity, risk if you get it wrong, and of course personalities. Some offices are better than others but it is not uncommon for higher visibility actions to be given to more experienced people / teams which frequently are familiar with these things. We just as easily could see info after the holiday as before it. Also some offices are tied up with preparations for the potential sequester. That may affect things as well. Again I don't know but in my opinion I would not be surprised to see it stretch out a bit.

      Sentiment: Hold

      • 2 Replies to anothos12
      • Good post and response indeed. Should remind us that if we want to press faster DEA action we really need to call and write our congressman errh... person and senator. That might be one way to make them feel that there is high visibility and someone will hold them accountable for unnecessary delays.

        Sentiment: Strong Buy

      • Hi Anothos, great post. I interact with government officials (NIH) and see the same dynamics you refer to, particularly the tendency to kick controversies upstairs on the "CYA principle". That's what has worried me all along about the 65+ comments on the FR; they may have created the impression of a controversy, one that needs higher level input. On the other hand, if there really is a legally mandated maximum response period, my general experience (of course less than yours) is that the government abides by it short of actually being shut down. So, yet more uncertainties...

 
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