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Arena Pharmaceuticals, Inc. Message Board

taylor6w 16 posts  |  Last Activity: Aug 21, 2014 9:20 AM Member since: Nov 23, 1999
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  • BPAC meeting originally tentatively scheduled for OCT 6-7 now rescheduled for DEC 2-3 !

  • No agenda yet. Lets keep our fingers crossed.

  • taylor6w taylor6w Aug 11, 2014 10:02 AM Flag

    "As should the US early use program and next year's FDA approvals for plasma and platelets,"

    Im glad to see you have finally moved out your approval timeline to something more realistic. Like I said we see this the same way, just my timeline is more like plasma 2015 midyear, platelets midyear 2016.The early use program doesnt mean anything in regards to speeding up the approval process. Forget Africa because no one is going to pay for it, said but true. They wont even pay for it EU on the scale it should be used now!But platelets with the extended outdate( 7 days) will make it cheaper and safer. Still hoping to see CERS pop up on a BPAC agenda soon.

  • taylor6w taylor6w Jul 21, 2014 10:46 AM Flag

    Our experience is that it is August and we dont have a clue when review?/approval? for plasma will take place. You say no BPAC just straight FDA approval comes out of the blue and says OK. I doubt it and we know the other plasma company had a review by BPAC and their product was used in EU for a decade too.

    Sure those %s for approval come out of my rear, but my rear has a little knowledge and experience concerning CERS and the FDA. You keep stressing the Kit is the same but you fail to acknowledge that only pertains to the safety of those 2 distinct products and not to their efficacy. It was on the efficacy that the FDA rejected Intercept platelets before and well might again. When CERS stressed the clinical outcome aspect the FDA ignored them and focused on the CCI, and they well might again. That is why my rear gave platelets a much lower chance of approval.

    Finally my rear would like to know why you think there will be no stoppage of time to answer concerns with platelets since coagulation factors are much simpler to compare and analyze than platelet data? So i factored a Q and A in. We pretty much agree on the final results but you are dreaming when it comes to the approval timeframe.

  • taylor6w taylor6w Jul 20, 2014 7:37 AM Flag

    Judging our experience with plasma I would say that it is very very unlikely. I would think once we get a BPAC review shceduled we will have some idea when platelets could be approved. If we get a plasma review in the Oct-Dec window we could get plasma approval by Mar-Jun 2015. We might be lucky and get a March 2015 review of platelets but Im guessing we wont get a review until at least the late second half of 2015. Earliest possible platelet approval in 1H 2016. Ill buy more if we drop below $3.25 which might be afeter the earnings call 7/31. You have to look long term here, keeping in mind platelets are everything to CERS survival. Plasma I think has a 90% approval chance but there is little market value, platelets failed before so I give it a 60% chance with a huge market value. Coagulation therapuetic data is pretty objective, platelet therapuetic data is somewhat subjective.

  • Reply to

    Cerus in big trouble!

    by hippocampus48 Jul 3, 2014 10:17 AM
    taylor6w taylor6w Jul 15, 2014 10:02 AM Flag

    The market always looks forward plus Im looking at PI platelets as becoming SOC very quickly. Platelets are the most contaminated blood product by far. 1.5 million platelet transfusions in USA alone yearly. Im sure the profit per set will exceed $50/set, thats $75M/year in USA easily. Canada will rubber stamp FDA approval. UK and many others will follow suit shortly. The pps will not wait until the revenue is realized. Did I say FDA approved platelets are a big thing!!!! A little bit of validation goes a long way. IMO

  • Reply to

    Expect CRIS to hit $2.50 in the near term

    by crishigh99 Jul 14, 2014 5:07 PM
    taylor6w taylor6w Jul 15, 2014 8:31 AM Flag

    Back in at $1.83, wiht the pipeline, collaborations, and number of clinical trials the odds are looking good. Hedge Hogs to infinitity and beyond.

  • Reply to

    Cerus in big trouble!

    by hippocampus48 Jul 3, 2014 10:17 AM
    taylor6w taylor6w Jul 15, 2014 8:06 AM Flag

    I dont think anything is really wrong here, just is going to take longer than anticipated. Yes, I do believe that hippo guy is right and the BPAC will need to schedule a review and we should get approval from the FDA from the FDA 30-60 days after. Platelet review and approval , if it follows the plasma tragectory, should come early 2016. The question is how low does CERS go and for what period of time? Hold, buy, trade? Keeping in mind that if platelets are approved this thing should rocket into the 20s.

  • taylor6w taylor6w Jul 10, 2014 8:11 AM Flag

    I am puzzled by the approval process. Im not 100% sure that plasma will be approved by the FDA without a BPAC review. If plasma does not need a BPAC review I dont know why platelets would. It seems to me both would undergo the same process.

  • taylor6w taylor6w Jul 10, 2014 8:02 AM Flag

    At least there seems to be some intelligent discussion going on here finally. Have followed CERS for a long time and am long the stock. One thing Ive learned is that it always takes longer than CERS guidance.

  • Reply to

    UNDERVALUED

    by michelet1 Jun 10, 2014 1:02 PM
    taylor6w taylor6w Jun 30, 2014 8:46 AM Flag

    CRIS at $1.60ish is a great buy IMO. Sold my 5K bought at 3ish backma ways before the steep decline. The value and large pipeline are worth much more but it is not recognized by the street. Could take a year or 2 until we see the recognition. So im buying back in here with a long term horizon.

  • has anyone any insight on why the plasma submission by CERS to the FDA is not being reviewed by the BPAC in July. The submission was completed early this year, you would think they had ample time by now. Is there a fly in the ointment here?

  • taylor6w taylor6w Jun 30, 2014 8:31 AM Flag

    I think your opinion of AF is way off. I dont agree with a lot of his analysis, but he at least does his research and supports his view. No one is more than 60% right when it comes to the biotech sector over a 5-10 year period. Believe me Ive been investing in the biotech sector since the 1980s. MNKD was just another one of his misses, and lucky for us it may be a VERY BIG miss.

  • July 31, 2014: Blood Products Advisory Committee Meeting Announcement
    Center Date Time Location
    CBER July 31, 2014 July 31 from 8:00 a.m. to approximately 5:00 p.m. 10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room, rm 1503. Silver Spring, MD 20993-0002

    Agenda
    On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

  • Hopefully intercept plasma will be on the agenda. Keeping my fingers crossed. Like Ive said before if we get an approval recommendation we will beat $6 in a heart beat. Also we will; have some hope that intercept platelets get approved in 2015.

  • Reply to

    Todays Trades

    by pankocamomile May 21, 2014 4:17 PM
    taylor6w taylor6w May 23, 2014 1:26 PM Flag

    To me this is nothing but market noise. I see no significance. The only catalyst would be a BPAC meeting to decide the FFP recomendation given to the FDA. The Platelet submission wont trigger an event until late 2015 at this rate, to me this way too early in that most significant process.

ARNA
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