Are Stem Cells Ready for Prime Time?

  1. 431 Posts.
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    Boy oh boy, lots of great developments since the last time I posted. It's been a while.

    First off, congratulations to all holders.
    This debt financing needed big cojones and I truly believe it was a very measured and calculated risk taken by SI. Timing is perfect.
    Just so that we can contrast this with a scenario I followed closely in the recent past:
    Linzess is made by Allergan and Ironwood. Had a big market share in the US. Enter Trulance (made by Synergy Pharma). Synergy went to market alone w/o a partner. Trulance is better than Linzess in efficacy and has less side effects. Yet, Trulance struggled mightily to capture market share. Reason: Existing competition. It's hard to usurp existing prescriptions with a new drug. On top of that, the CEO of Synergy played his cards really bad, taking on debt with bad clauses attached. Result: Synergy sp tanked. Lawsuits followed. Synergy should have partnered but didn't. Bungled.

    Well, for Mesoblast, there is no competing drug/treatment for pediatric aGvHD. That is the biggie right there. No games, no butting heads with any pharma out there. The same is true for Class 4 and Class 2/3 CHF. We might run into some inferior "competition" for CLBP and RA, but by then, Mesoblast will be a juggernaut and can hold its own.
    So SI knows aGvHD is a winner and so does Bluestein. He has done financing for lifesciences companies before and understands US markets (he is based out of Boston, MA).
    There is no risk now other than FDA not approving aGvHD (I have to throw that in there for the sake of a balanced perspective).

    The key is to get an FDA approved product. Most investors I know in this space ask this question:
    "Does the company have any FDA approved product(s)". If the answer is yes, that changes their whole perspective. So the key (again) is to get that FIRST product approved. That gives Mesoblast the recognition.
    I can tell you that Mesoblast is hardly a known entity in the US stock market even today. That will change with the first FDA approved product. Book it.

    Partnerships: Or lack of. I can tell you that there has been a frenzy of big pharma M&A and partnerships recently but it has been mostly in the cancer space. For whatever reason, cancer is where the focus is right now. So I am not surprised by no one coming to the table yet for Mesoblast. Stem Cells can wait, seems to be the perception of big pharma. But the FDA doesn't think so. See below.

    Finally, as to the heading of my post...
    The FDA hosts a bimonthly "Grand Rounds" session. There is a session tomorrow (US time anyway) that is being held by Steven Bauer, Ph.D.
    He is the Chief of Cellular and Tissue Therapy at the FDA.
    The session is titled:
    Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine

    It's a webcast lecture and you can attend and ask questions, if you are interested. Be sure to register right away since they require early registration. Do the math to figure out your local AUS time.
    Here is the link:
    https://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm486711.htm

    PS: Great posts from all holders the past few days. I have read a few and will read more as time permits. Thanks for all the great contributions folks.
    Last edited by The Yankee: 08/03/18
 
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