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Epizyme, Inc. Message Board

  • regulatoryexpert Nov 22, 2013 10:38 AM Flag

    This is Risky Stock-RegulatoryAnalysis

    The following are facts:
    1) Greater than 90% small/emerging biotech companies are failure
    2) Companies staffed with fundamental scientists (PhD/MDs in lab experiments or in vitro/in vivo science stage) at the management level is where most of the failure occur
    3) People who claim that they worked on some approved therapies in their Bios, please pay more attention and you will find that he/she is far from the actual drug development staff who really enabled the approval.
    4)Drug development/Regulatory development is only gained via actual experience and no school out there teaches these regulatory and scientific standards that pushes drug from IND enabling studies transitioning into Phase 1 to Phase 2 or Phase 3 and navigating through FDA/EMA regulatory authorities.
    5) Some of theses inexperienced scientists and I have seen a nobel laureates canot differentiate what an API Vs Drug product or what is a prodrug Vs Identical new molecular entities from the regulatory development science perspectives causing immense delays as well as premature failures or sometimes spending too much money on false positive signals. (AVEO, Delcath, Aria, SRPT ....etc)
    So my bottom line analysis says that Epizyme is very risky stock because none of the management members has actually saw a drug transition from early development all the way to approval. PhDs/MDs are mostly academic experienced or fundamental science experience in industry who are only capable to look good on paper and perhaps good in publishing papers but certainly not drug development experts. I will not invest in this stock in its present form.

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