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ImmunoGen, Inc. Message Board

azelfage 28 posts  |  Last Activity: Mar 31, 2015 11:25 AM Member since: Nov 11, 2010
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  • Reply to

    CMC & CMO - help me figure this out.

    by crecy_war_knight Mar 28, 2015 10:42 AM
    azelfage azelfage Mar 31, 2015 11:25 AM Flag

    But then it gives the image that it was 100% management's fault the delay.... And a lot needs to change, the CEO is not enough? I thought any data tied to a contract, belongs to the customer, not the contractor.

  • azelfage azelfage Mar 31, 2015 10:02 AM Flag

    Indeed it is very rare to have an "active" CNS drug without much SEs (to the point that some scientist would think a CNS drug is not "active" if the SE profile is too clean). A few years back, the company I was working for had a historic CNS product with very clean SE profile. It turned out that the plasma and tissue half-life of the product was a few seconds. A few regulators actually took it off the market once they were aware of the PK/PD data, decades after its first approval. Some other countries are still using the drug to "treat" patients.

  • Reply to

    Why no licensing deal out of USA?

    by azelfage Mar 30, 2015 10:59 AM
    azelfage azelfage Mar 31, 2015 9:53 AM Flag

    What about several years of delays for revenues out of USA while the patent life shrinks? If there is no problem with the data and the dosier, potential partners would not give a damn about the FDA process. Why is then all the other similar companies outlicensing ex-US rights much earlier (give me a single example of a company that waited FDA approval to do ex-US licensing - small obscure products don't count). And companies typically outlicense in Far Eastern Asia very very early in the process, so that Asian trials can be run in parallel.

  • Reply to

    CMC & CMO - help me figure this out.

    by crecy_war_knight Mar 28, 2015 10:42 AM
    azelfage azelfage Mar 31, 2015 5:50 AM Flag

    Isn't it worrying that ACAD hasn't changed their CMO after two years of major failures? Normally 6 months is more than enough to set up commercial stage production and put together the CMC dosier as long as you have done your homework during early clinical stages.

  • Reply to

    Why no licensing deal out of USA?

    by azelfage Mar 30, 2015 10:59 AM
    azelfage azelfage Mar 31, 2015 5:38 AM Flag

    Again and again, you guys oppose my points but come up with NO counter argument. What do you mean by "absolutely nothing to do with acad"? Are you joking? PWC quit as auditor of ACAD right after the no filing and CEO gone announcement. And this academic has done a research and says that quitting auditor is bad news for stock. Straightforward.
    And you guys cannot give one good reason why Acad has not outlicensed rest of world rights.

  • Reply to

    Why no licensing deal out of USA?

    by azelfage Mar 30, 2015 10:59 AM
    azelfage azelfage Mar 30, 2015 1:29 PM Flag

    and while you are at it why don't you also google
    "Auditor Quits: Warning Sign of Stock Risk"
    and tell us what you think on that article...

  • Reply to

    Why no licensing deal out of USA?

    by azelfage Mar 30, 2015 10:59 AM
    azelfage azelfage Mar 30, 2015 1:06 PM Flag

    Why do you ignore me with capital letters?
    Why don't you instead explain to us potential reasons for not signing an ex-US deal?
    Nobody would believe that a company like ACAD can on its own commercialize such a "big" product worldwide. Sensible thing would have been to outlicense it outside of USA after the PIII results (latest) so that the partners can work in parallel for additional R&D, regulatory files and other launch preparations.

  • I would buy the argument that the delay was purely technical. But because they haven't done a licensing deal for two years in EU or Far East after the PIII data, I am finding it difficult to believe the claims. If you are in positive territory, do not wait for a third time disappointment. If you are at a loss, do not throw good money after bad... You won't be able to forgive yourself.

    Sentiment: Strong Sell

  • Reply to

    ACAD review

    by crecy_war_knight Mar 26, 2015 10:32 PM
    azelfage azelfage Mar 27, 2015 2:19 PM Flag

    I would buy the argument that the delay was purely technical. But because they haven't done a licensing deal for two years in EU or Far East after the PIII data, I am finding it difficult to believe the claims. If you are in positive territory, do not wait for a third time disappointment. If you are at a loss, do not throw good money after bad... You won't be able to forgive yourself.

  • Reply to

    WAG

    by gilmangrayjr Mar 24, 2015 1:43 PM
    azelfage azelfage Mar 24, 2015 2:07 PM Flag

    Have you asked yourself, why there has been no licensing activity for Europe, Japan or China? If this is the blockbuster in making, and lets say ACAD wants to keep US to themselves, why haven't they done anything for other markets? Time is ticking and value is being wasted....

  • Reply to

    ADP study is NOT progressing

    by azelfage Mar 20, 2015 9:22 AM
    azelfage azelfage Mar 20, 2015 11:26 AM Flag

    when you start a pivotal trial, you usually commit to an open label extension study, that is called ethics. and you typically put the drug material aside for that.. so such a study is not by choice, it is by necessity. if you are confident with your package, you go far beyond that... you commit to label expansion studies, not open label extension studies...

  • Reply to

    ADP study is NOT progressing

    by azelfage Mar 20, 2015 9:22 AM
    azelfage azelfage Mar 20, 2015 10:33 AM Flag

    can you please name us an active study site for ACAD?
    not one active study and they are burning $10 million per month... that is more than $250m since the p3 study ended...

  • Reply to

    ADP study is NOT progressing

    by azelfage Mar 20, 2015 9:22 AM
    azelfage azelfage Mar 20, 2015 10:16 AM Flag

    My guess is that there is a serious problem with the pharmaco package or manufacturing. It could be that they are not able to produce new batches that match the early clinical trial material. If that is the case your safety and efficacy data so far is useless and you have to do em all again. That may be the reason why they are not doing any new trials (no good drug in hand to use in trials). if you have clinical trial drug material in hand and if you are confident that you can match that material with new production, then you would keep on going with your clinical trial programme. not doing so would be huge loss of potential value to the shareholders.

  • Reply to

    ADP study is NOT progressing

    by azelfage Mar 20, 2015 9:22 AM
    azelfage azelfage Mar 20, 2015 10:04 AM Flag

    do you know what a p4 study is?
    why are they then claiming that the p2 ADP study is recruiting and progressing?
    surely a positive p2 ADP data would hugely increase off label prescriptions...
    you are not in a good place.... calm down and reflect a little bit more...

  • Reply to

    ADP study is NOT progressing

    by azelfage Mar 20, 2015 9:22 AM
    azelfage azelfage Mar 20, 2015 9:47 AM Flag

    if a company is confident (they said they are confident a million times in the last telecon) with their registration stage drug, why are they not running any p4 or label extension studies?

  • according to clinicaltrials.gov, acadia has only one study that is currently recruiting patients and that is the p2 ADP study. and in response to an analyst q, the management said that the p2 ADP study is "progressing". the study is listed as based in london, UK. however no specific site (hospital or clinic) has been registered yet. this tells me that the p2 ADP study is NOT recruiting and the "progressing" comment from the new management is misleading.
    * i have emailed the trial manager and investor relations and if they respond, i will let you know immediately

  • i thought they had enough cash in the bank...
    any comment on why they might have decided to raise more?

    Sentiment: Hold

  • Reply to

    one more downgrade

    by azelfage Jan 16, 2015 12:14 PM
    azelfage azelfage Jan 28, 2015 9:01 AM Flag

    tim, tim, tim,
    against all my arguments, all you can say is that i must be new to the story...
    what must be your mental age?
    i did short alxn, made my money, and am out now...
    alxn bubble will burst at some point. i am not going to bid on when that might be.
    the question is more relevant for long term alxn holders...

  • Reply to

    where is me pipeline?

    by azelfage Jan 8, 2015 10:42 AM
    azelfage azelfage Jan 21, 2015 11:24 AM Flag

    have you heard the term synergy... it is an important term you know?

  • Reply to

    where is me pipeline?

    by azelfage Jan 8, 2015 10:42 AM
    azelfage azelfage Jan 20, 2015 4:49 PM Flag

    I won't even address your comical acquisition suggestion.
    But at least you seem to agree that ALXN has a pipeline problem...

IMGN
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