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Afrezza may miss PDUFA date: Cowen, Piper

  • Cowen and Piper are reportedly out expressing some skepticism about the chances of Afrezza approval by the PDUFA date.
  • The concern: The timing of the Ad Com (announced today) may leave too small of a window to get the inhalable insulin product reviewed by April 15.
  • Shares of MannKind (MNKD -15.5%) look to close sharply lower on the day.
Comments (13)
  • Welt
    , contributor
    Comments (110) | Send Message
     
    I can't believe the moves that this stock has made the last two days. I would say both up and down days were exaggerated to a HIGH degree.
    10 Jan, 03:42 PM Reply Like
  • JayXu
    , contributor
    Comments (258) | Send Message
     
    Painful....
    10 Jan, 04:14 PM Reply Like
  • norjud
    , contributor
    Comments (191) | Send Message
     
    This drug a winner...who likes Insulin Shots...please raise your needle!!!
    10 Jan, 04:35 PM Reply Like
  • fish1golf2
    , contributor
    Comment (1) | Send Message
     
    Bailed at 5.97 Wed. Mourned all day yesterday. Then today............? Buy back in?
    10 Jan, 04:51 PM Reply Like
  • Welt
    , contributor
    Comments (110) | Send Message
     
    Might need to let it settle a little while and see if it can hold current prices at least.

     

    I am long from Monday @ 5.71 and sold just over half at 6.30 yesterday.
    10 Jan, 04:58 PM Reply Like
  • dnachef
    , contributor
    Comments (36) | Send Message
     
    A possible delay in PDUFA date really only affects options holders. That would really be unfortunate if April or May options expire before a decision is released. But for common stock holders, a possible delay isn't that big a deal. Many of us long term investors have been holding for years. What's a couple more months. Also, you could interpret this small two week window between ADCOM and PDUFA to mean the FDA isn't too worried that they will need a lot of time to make a final decision. I think that's bullish because the FDA had plenty of time to schedule an ADCOM in February or March if they felt they really needed a lot of time to digest the recommendations and data. As far as I know, the PDUFA date has not been moved back.
    10 Jan, 06:21 PM Reply Like
  • dfedak
    , contributor
    Comments (114) | Send Message
     
    I see this as bullish as well. Read the following below to see some of the reasoning.

     

    "MannKind (MNKD) will bring its inhaled, rapid-acting insulin Afrezza in front of an FDA advisory panel on April 1. [Insert April Fool's Day jokes here.]

     

    In today's Biotech Stock Mailbag, I elaborated on my prediction that FDA would reject Afrezza. That was before the FDA panel announcement, so let's discuss further.

     

    I see the scheduling of a panel for Afrezza as a MannKind negative, indicative of FDA's problems with the Afrezza data. At best, it's another risk that will hang over the stock until April 1.

     

    I've always had my doubts about MannKind's ability to find a marketing partner for Afrezza, despite the company's assurances that negotiations were underway. It's hard now to see any potential partner taking on the risk of Afrezza in front of this FDA advisory panel.

     

    This morning on Twitter, healthcare investor (and TheStreet contributor) Aafia Chaudhry @aafiac argued the scheduling of a panel betters the odds of Afrezza approval, in part because 1) FDA almost never approves a diabetes drug without first holding a panel; and 2) A panel endorsement is absolutely necessary for a unique product like inhaled insulin. She implies that historically, experts on FDA panels have been more lenient and supportive of new diabetes drugs than the FDA itself.

     

    Aafia's points are well taken but on balance, I still see more risk to MannKind because the Afrezza data are a black box. The only data investors have seen come via MannKind press releases. In April, we'll get a far more objective -- and critical -- take on the Afrezza data when FDA posts its review ahead of the April 1 panel.

     

    I expect the FDA's briefing documents to raise a lot questions about the efficacy and safety of Afrezza. I think we'll also learn a lot more about the interactions between FDA and MannKind over the last several years, some of which won't put the latter in a favorable light.

     

    I'm really looking forward to live-blogging this FDA panel. April 1 can't come soon enough."

     

    -- Reported by Adam Feuerstein in Boston.

     

    http://bit.ly/1a72oLb
    10 Jan, 07:20 PM Reply Like
  • Llewyth
    , contributor
    Comments (38) | Send Message
     
    If Afrezza is Approved, the company is worth from 10 to 140 (seeking alpha scenarios).
    If not is worth 1-2 USD.
    50 of the theoretical value = 65 /50 afrezza approved= 32 /50 more discounting = scenario gives: 16 now.

     

    Mr Mann is 87 young. He is invested 50% in the company, with 40% of his assets.
    Speaking about endorsement. This is the kind of Mann that made America great.

     

    FDA is clearly a corrupt agency in many senses, but if it works they will have to approve it.
    I would point to the fact that if you buy @ 6 the risk is to loose 80 % or to make 100% times on the long run (3 years).
    11 Jan, 08:27 AM Reply Like
  • norjud
    , contributor
    Comments (191) | Send Message
     
    I see NO safety problems from the studies I've read. The pts lung function FEV1 was ~.001 less on this drug. The highest SE was cough at 30%, usually went away after a few days, approx. 4% discontinued because of this.
    Lets face it...diabetics SKIP shots and if you don't believe this you are in denial.
    This drug is a NO brainer.
    11 Jan, 12:23 PM Reply Like
  • patriot_invstr
    , contributor
    Comments (38) | Send Message
     
    Yesterday was a wild ride. I am long @5.50 and will add more if it goes that low again. As someone with a family member who has to use insulin shots, I think this will be a breakthru in terms of convenience and efficacy.
    11 Jan, 01:15 PM Reply Like
  • Billy Rolex
    , contributor
    Comments (6) | Send Message
     
    I have been long MNKD since 2008, adding and selling positions along the way. I have always kept a core holding and will till the FDA decision. This stock will reward the few with the guts to hold on.
    11 Jan, 02:54 PM Reply Like
  • diabetesinvestor1
    , contributor
    Comment (1) | Send Message
     
    I think too much emphasis has been placed on the April 15 PDUFA date possibly being pushed back. Volatility will create exciting trading opportunities as April 1st approaches for ADCOM. What is most intriguing to me is the prospect of what may happen if the ADCOM recommendations to FDA are favorable and a bidding war between potential suitors then ensues. This is actually a most exciting prospect. Pushing date back for formal approval then works to push price of stock up on further speculation. Imagine the short squeeze which could result from a bidding war or partnership announcement with the vote of confidence provided by ADCOM well before the PDUFA date. NOVO especially is VERY nervous about the future prospects of Afrezza, while others like Lily, Glaxo, Roche, and even PFE are chomping at the bit to land the next blockbuster drug to renew their expiring drug offerings. My prediction is that there will be wild swings in the forward direction (3 steps forward, 2 steps back) as we approach April, and that if ADCOM verdict is favorable, it's off to the races!!!
    12 Jan, 09:48 PM Reply Like
  • PICOLOMINI
    , contributor
    Comments (538) | Send Message
     
    I am worried about another Lemtrada (Sanofi) SNY event, approved for Europe and Canda but where the division manager had an obvious bias against this new MS drug and it was rejected for the US. There is now a petition to the FDA for patients to sign up to.
    I think that should be a pre-emptive PR campaign/ open letter to the FAD by diabetes patients in support of Afrezza.
    13 Jan, 07:41 AM Reply Like
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