I read this announcement as a 6 month delay. Patient recruitment to now start Q4 2020, previously end CY 2019. This from a previous trial update:
The current US FDA 510(K) approval relates to sales of NovoSorb BTM for clinical indications outside of full
thickness burns. Achieving a PMA for the NovoSorb BTM will allow for portion and sale for full thickness
burns and opens the possibility for BARDA to acquire a stock pile of NovoSorb BTM for use in disaster
management. It will also be the only synthetic dermal scaffold on the market with a PMA.
We will now commence, concurrent to monitoring the existing patients, the building of the protocol and
dossiers required for the next phase, the Pivotal trial. This phase will require a new budget submission and
contract award from BARDA. We expect to complete document submissions by the end of this financial
year and commence recruitment into the Pivotal trial by the end of CY 2019.
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I read this announcement as a 6 month delay. Patient recruitment...
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