Getting ready for the BLA, CMO and mono trial data
Post# of 148187
Fro 2017 10K
Quote:
In connection with this undertaking, we entered into an arrangement with a third party CMO to provide process transfer, validation and manufacturing services for PRO 140. Management believes our CMO will best serve our strategic objectives for the anticipated BLA filing and, if approved, the long-term commercial manufacturing capabilities for PRO 140. Management will continue to assess manufacturing capacity requirements as new market information becomes available. In the event that we terminate the agreement with our CMO, we may incur certain financial penalties which would become payable to the CMO. Conditioned on the timing of termination, the financial penalties may range from an approximate low of $1.2 million to an approximate high of $3.6 million. These CMO undertakings are anticipated to require approximately $25 million of additional capital over the next two calendar years, including the estimated costs to fill, label, and package product into the final commercial package for commercial sale.
From 2019 10K, cost of R&D, almost all supporting completing BLA