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Vertex Pharmaceuticals Incorporated Message Board

irc203 12 posts  |  Last Activity: Jun 4, 2014 11:10 PM Member since: Nov 24, 2002
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  • Reply to

    It's simply way too late to sell

    by iceman3223ice Jun 4, 2014 10:04 PM
    irc203 irc203 Jun 4, 2014 11:10 PM Flag

    Do we get the 300 patient DSMB before June 24 & 25 JMP Healthcare Conference?

  • irc203 irc203 Jun 1, 2014 10:57 PM Flag

    Dacogen is an HMA that is used to treat MDS as is Azicitidine. Sapacitabine will be used to treat MDS after Dacogen or Azicitidine fails. That is why cytarabine is being used for the control arm.

  • irc203 irc203 Jun 1, 2014 12:54 PM Flag

    Communication and public relations may be their biggest problems. Their new PR firm has their work cut for them. I sent an email this morning to Robert Flamm of Russo Partners describing my perception of their communication problems and ideas for improvement. I think as shareholders we should make our voices be heard by management.

  • Reply to

    3 more years cah burn rate. ouch !!!

    by jk4763 Jun 1, 2014 10:27 AM
    irc203 irc203 Jun 1, 2014 12:45 PM Flag

    Hopefully they will form an alliance with another company obviating the need for a capital raise. It is time for managment to begin earning their keep.

  • irc203 irc203 Jun 1, 2014 12:40 PM Flag

    Value, Ice I am as disgruntled and frustrated as any of the longs with management. But one thing I find interesting about the MDS development plan is how it was considered in context with Seamless. Seamless is an open trial design. The investigators know who is receiving decitabine and sapacitabine and who is only receiving decitabine. I can't help but think as a consequence Dr. Kantarjian, lead investigator, and CYCC managment know how the trial is going to some extent. If management does indeed have knowledge of how Seamless is going and used this knowledge in formulation of the MDS plan, then their approach may not be as bad as we think. If Seamless succeeds, their MDS trial design may very well result in early approval of Sapacitabine if the MDS results are good. Seamless approval would make the MDS results much more persuasive.

  • irc203 irc203 Jun 1, 2014 12:16 PM Flag

    It was the sharp drop off in the DACO- 016 KM curve relative to low dose cytarabine that caused the results of the trial to lack statitstical significance. Had the drop off not occurred, the improvement in OS of Dacogen over low dose cytarabine would have had statisitcal significance and would have probably been sufficient for approval assuming they could overcome the geographical variability of the trial results.

  • irc203 irc203 Jun 1, 2014 12:27 AM Flag

    They may be slow rolling the MDS trial so they can avoid another cash raise until something develops. If they were at all intelligent they would make a deal with another company. They have European rights, US rights, etc. to sell or partner with. And they have their ATM with Aspire. Maybe they are not as incompetent as we think, then again….

  • Reply to

    disgrunted longs

    by winstoncheok May 31, 2014 11:29 PM
    irc203 irc203 Jun 1, 2014 12:14 AM Flag

    You are right Ice. May as well hold. Except for any knee jerk reaction that may occur on Monday, I think this plan for the most part is already baked into the share price. The stock started to go down before the last raise and has continued down further. The plan isn't necessarily all bad. Just disappointing the way Spiro and company went about it. Later this month CYCC will make a presentation at the JMP Heathcare conference on the 24th or 25th.

    If they were smart they would drop the lead in part of the trial and take a year off the timeline from 16-17 to 15-16. I emailed Paul McBarron to that effect as well as IR. I think all shareholders should email management and tell them to drop the lead in trial and perhaps the feasibility study unless the feasibility study can reduce the trial time in some way.

    Spiro must have grown up on a dairy farm the way he is milking this. But in his defense, I must admit he is doing the work of 3 men,- Mo, Larry, and Curly.

  • irc203 irc203 May 31, 2014 11:23 PM Flag

    Value, the results of the first set were not much different if I remember correctly. CYCC managment reminds me of General George B. McClellan's cautious approach to waging war against the confederacy. Lincoln saw his cautious approach for what is was and relieved him of command.

  • Reply to

    Dr. Kantarjian's upcoming presentation

    by hopspr May 29, 2014 8:15 AM
    irc203 irc203 May 31, 2014 4:07 PM Flag

    Are you suggesting some sort of fast track leading to AA depending upon the results of a small trial? Your idea ties into the Q & A banter between Judy and Spiro on the 4th quarter call with respect to two trials or one large trial and Judy's comments on AA conversion to regular approval requiring the trial to be for the same indication. It also ties into the limited capital raise that was undertaken with Laidlaw. It also ties with the use of the term "RCT." But under your scenario, Spiro was exaggerating the importance somewhat of CYCC's ability to scale production of commercial quantities of Sapacitabine quickly.

    I think if a small trial is undertaken and it is pursuant to a fast track application or designation with a view towards AA based upon the results of the small trial, the share price goes higher assuming CYCC executes the plan expeditiously. If they lollygag, it may be a different story. Patience has worn very thin in many quarters based on experience. I hope to hear Judy say they are seeking fast track designation if not accelerated approval.

    Why do you believe a surrogate end point is the missing piece for AA approval now? I thought a clinical endpoint or a surrogate end point could be used. Is there not an existing clinical endpoint that could be used?

    Certainly Dr. Kantarjian's commentary will be important for the market. While management may not have any credibility in some quarters, Dr. Kantarjian's integrity is beyond reproach.

    Thanks Hops. The wait is not too much longer. Best regards, IRC

  • Reply to

    Dr. Kantarjian's upcoming presentation

    by hopspr May 29, 2014 8:15 AM
    irc203 irc203 May 31, 2014 12:43 PM Flag

    Hops, always good to read your posts. What do you make of management's use of "RCT" to describe their plans for their registration trial, the holding of the special presentation tonight with Dr. Kantarjian, Spiro's reference to CYCC's ability to ramp up production of Sapacitabine to commercial quantities quickly in the 1st qtr CC, and Judy's oblique reference to AA in the Q & A of the 4th qtr CC? Why not refer to the RCT as a phase 3 trial? Are they trying to obscure the fact the upcoming trial is another phase 2 trial? Their remarks and use of "RCT" to describe their planned trial creates some hope of an AA announcement of some sort tonight. Why the teasers for the show tonight if they are not going to deliver something substantial? Why have the show if they are not going to deliver with something substantial? Why even bother with teasers, why not just deliver? If they tease and don't deliver, they will further damage their credibility, if that is possible.

    On August 25, 2012, I emailed Corey with the following question:

    Could the accelerated approval provisions of the new legislation for
    rare diseases apply to Sapacitabine and/or Seliciclib for solid tumors
    or to Sapacitabine for MDS or AML?

    He responded on August 28, 2012, as follows:

    "Both the FDA and the European Medical Agency have designated
    sapacitabine as an orphan drug for the treatment of both Acute Myeloid
    Leukemia and Myelodysplastic Syndromes. When appropriate, we and our
    collaborators may attempt to seek fast track designation or accelerated
    approval for our drug candidates."

    Could Dr. Kantarjian and company be the collaborators referenced in his response? Could now be the time appropriate to seek fast track designation or accelerated approval?

    How are you handicapping tonights event?

  • Reply to

    ice doesnt own a share

    by adiamondintheruf May 28, 2014 5:08 PM
    irc203 irc203 May 29, 2014 12:24 AM Flag

    i personally know Ice. He is long, with a substantial number of shares.

    Sentiment: Buy

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