MSB 1.01% 98.0¢ mesoblast limited

Ann: FDA Grants Orphan Drug Designation for Revascor, page-28

  1. 7,507 Posts.
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    Contrary to comments above, it should very much will drive stock price gains as MSB's fortunes dramatically improved:

    "The results, on average, show that the stock price of a company increases by 3.36% after the announcement of the designation, increasing the value of the company. The results are more pronounced for oncology drugs, and drugs being developed by the smallest companies."

    (empirical study on ODD effects - https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0665-6)

    "For the fast-track designation, the most recent event study estimated an average stock price increase of 6.25% after the announcement of the designation occurred [15]. Studies conducted in the earliest years of the program found increases of between 9 and 10% [16, 28]. These are both large effects, and seem to indicate that investors place strong, positive value on the information conveyed by the announcement of a fast-track designation, and therefore believe that it warrants an increase in the company’s value. Given that the orphan designation provides information, as well as tangible financial incentives, investors should react to its announcement in a similar manner to that of a fast-track designation. However, no previous studies of the orphan designation could be found."

    ...and no wonder amplified in MSB's case RPDDesignation':

    "Orphan designation qualifies the sponsor of the drug for various development incentives, including eligibility for seven years of market exclusivity upon regulatory approval, exemption from FDA application fees, tax credits for qualified clinical trials, and other potential assistance in the drug development process."

    Empirically and fundamentally, MSB's chances just improved significantly:

    "The financial incentives offered by the ODA are substantial and include tax credits up to 50% of the qualified clinical testing expenses for the taxable year".

    https://www.eversana.com/insights/critical-success-factors-for-launching-products-with-orphan-drug-designation/

    This a little golden egg for - even the most optimistic investor has to agree - cash strapped MSB.
 
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