TYPE A OUTCOME AND NOVARTIS PARTNERSHIP, page-5

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20/11/20

08:54

Post #: 49008613
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Originally posted by vorzaw: ↑

Taken from the report

On November 17, 2020, a Type A meeting was held with the FDA to discuss the review of the BLA for remestemcel-L and a
potential pathway for accelerated approval with a post-approval requirement to conduct an additional randomized controlled study in
patients 12 years and older. At the current time it appears that the FDA review team will not agree to accelerated approval. However,
the definitive outcome of the Type A meeting will not be known until Mesoblast receives the formal minutes which are expected
within 30 days of the meeting. If the current review team does not agree to accelerated approval, Mesoblast will request a further Type
A meeting to initiate the well-established FDA dispute resolution pathway.
Page 35
On November 20, 2020, the Group entered into a worldwide license and collaboration agreement with Novartis for
the development, manufacture and commercialization of remestemcel-L, with an initial focus on the development of the treatment of
acute respiratory distress syndrome (“ARDS”), including that associated with COVID-19. The Group will retain full rights and
economics for remestemcel-L for graft versus host disease, and Novartis has an option to, if exercised, become the commercial
distributor outside of Japan. The Group will receive $50.0 million in proceeds consisting of an upfront payment of $25.0 million
and $25.0 million through the placement of new fully-paid Mesoblast ordinary shares on closing of the license agreement. Closing
of the license agreement is subject to the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust
Improvement Act and certain other conditions. The Group may receive a total of $505.0 million pending achievement of precommercialization milestones for ARDS indications. The Group may receive additional payments post-commercialization of up to
$750.0 million based on achieving certain sales milestones and tiered double-digit royalties on product sales. The Group has not yet
assessed the accounting impact of this agreement

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i see politics in play with the FDA stalling...not at all surprised....novartis now in play with us...they're readiness to invest,for me is far more credible than the silly political FDA game..terrific

MSB Price at posting: $3.27 Sentiment: Buy Disclosure: Held
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