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DURECT Corporation Message Board

  • draycott250 draycott250 Jan 11, 2011 9:52 AM Flag

    FDA response

    Cupid: Your thoughts on FDA response?

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    • The previous press release does NOT signal acceptance, only that the NDA was resubmitted. In most every 2nd cycle submission, there is a 2nd cycle acceptance press release issued, which in this case I will expect in February.

    • Let's stop the hyperventilating here. The Remoxy NDA has been resubmitted and the fact of a joint KG/PTIE PR to that effect signals FDA acceptance. The strike price of stock option awards/grants to management has absolutely nothing to do with day to day share price fluctuations. Somebody is liquidating and this too shall pass.

    • "Did anyone with a brain really think I had bought MNKD..."

      You betcha!

    • I guess the "Red Herring" disguised the humor of my last post.

      Did anyone with a brain really think I had bought MNKD because of emails from the gang like boors,septis,bugs, Mr. A, etc.? Could/would they have really emailed me recommending I buy MNKD ( that's funny)? I have never owned any shares of MNKD thankfully. Did I really own only 237 shares of DRRX as I posted trying to be humorous to some?

      I trimmed my position in DRRX considerably at $3.58 seeing DRRX stuck there for some reason. Then I trimmed again yesterday at $3.37. Those were great moves but I still own a great deal of DRRX and my profits temporarily diminished a good bit of course. I intend to buy back some shares.

      So, I am still here for the glory that DRRX can provide for us. Today was some pain but we should recover.

      AFFY and HBAN made nice moves for me today. I have added a significant position in CLDX lately below the current PPS. Worth DD IMHO.

      Have a nice weekend. Keep the faith.

    • 4all, I am sorry for the loss of your MNKD investment. Truly I am. But at least you are no longer in DRRX anymore while I, unfortunately, must watch and lament as my DRRX investment continues to fall . . .
      But I don't blame YOU. No, though I followed your advice and bought into the dream of spending my golden years at the DRRX Hilton recounting to young ladies how we brilliantly rode that magical dragon DRRXalot to success - I still do not blame you. In fact, I am now starting to believe there is a fairly optimistically good chance that MNKD and DRRX will now team up to create an abuse-resistant Afrezza-filled Oradur suppository! Yes, I believe that would be a brilliant idea! Why didn't I think of that? Wait a minute . . . I DID!
      Good luck 4all. Keep your chin up. Raise your lance and tilt hard. There's an even bigger windmill up ahead.
      And remember, one 4all and all for one 4all and all for one 4all and all for one 4all and all for one 4all and all for one 4all and all for one 4all and all for one . . . . . . . .

    • "...bought MNKD ( boors, Mr. I( A ), bugs, septis, and some others had emailed me to do so)."

    • drrx4all -- you are pathetic
      name calling, outrageous fantasies, bogus stories.
      BTW, i neither own nor short DRRX; my interest in this board / stock is merely one of curiosity.

    • If you figure in weekends and holidays, the FDA should advise KG of NDA acceptance on or before December 18th. Given year end vacation schedules and holiday distractions and normal FDA delays, my guess it will be on the 18th then figure in 48 hours for PR.

      Time to stop day trading and hold max long position.

      • 1 Reply to rak5555
      • I am of the opinion that we have read all we're going to read about the resubmission for the time being. Obviously you haven't been paying attention, rak, and it's time to move on to more substantive subject matters. How 'bout speculating on the contents, import and anticipated publication date of KG's Remoxy abuse liability (liking) study in a peer reviewed journal. What might that do for share prices?

        Back to the resubmission matter: on Decmber 17 I posted this on the PTIE MB: "For all we know, the 14 day acknowledgement clock is running as I write. KG will announce (by PR) acceptance when the receipt letter is in hand."

        Now let's parse what KG's December 27 PR actually said. Hat tip to ref for his insight on this aspect of the resubmission and apologies in advance for my not so subtle editing:

        "CUPERTINO, Calif., Dec. 27, 2010 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq:DRRX - News) today reported that King Pharmaceuticals, Inc. (NYSE:KG - News) and Pain Therapeutics, Inc. (Nasdaq:PTIE - News) HAVE [emphasis added] announced that King HAS [has emphasis added] resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle. [Nothing stated in the preceding sentences should neccessarily be construed to mean that December 27 is the actual date of the physical resubmission. A little wiggle room is a good thing and our ambiguity is deliberate.]"

        While on the subject of debunking red herrings, I am of the opinion that completion of the PFE/KG business combination is already largely baked into the share prices of the down stream beneficiaries (PTIE and DRRX). KG's share price behavior would seem to indicate that matters are on track.

    • BTW, 2 other technical signs are 1. the Friday close was the second highest close in over two years, and
      2. There is a large buyer (s) showing up again to buy very many shares late in the day each day. This buyer (s) think DRRX is headed up.

      Does anyone think Venrock knew what they were doing when they bought millions of shares at $2.25?

      All we had to do was follow their lead. Some dummies needed convincing.

    • I also look forward to Cupid's response if he get's the time to do so.

      Here is my uninformed speculation. KG submitted the refiling on or before Monday December 27,2010. I thought it was posted here with a link refering to a 10 day normal response time by the FDA to simply accept or reject the resubmission. I presume that is 10 business days which have now past.

      I presume we will see a response within three days from now, meaning either today or before the weeks end.

      I may again be totally wrong, but I do not think so. I would be happy to be corrected.

      Good luck.

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