Thank you swg_tdr - this is at the heart of advanced preparation for commercialization but there are a few pathways one can take.
Costs for standing up a biotech manufacturing space can run from the low tens of millions to well over $150M. This includes full manufacturing through fill/finish, storage logistics and other incidentals.
Construction of a line, in an existing and fit structure (i.e. no building to build and no major structural/environmental remediation), can take on the low side of 12 months to the high side of 24+ months.
Funding this type of endeavor is costly and ATM type funding, or bulk sale (same prices as ATM) can hit hard on outstanding shares. That said - it is not a cost one can hold back from spending as capacity is a must for both approval as well as the ability to turn science into sales.
There are other options for anyone in a bind, including the ability to carry out a 'technology transfer' where augmenting a Toll Manufacturer into the supply chain enables one to leverage someone else's manufacturing space and establish additional capacity. That allows for a somewhat faster expansion, and certainly cheaper (short term) way of standing up capacity.
Where Peregrine goes is hard to tell - but my gut says they have the ability to divert capacity used to support customers into Bavi manufacturing given sufficient time. It is also likely they will use a Toll Manufacturing (third party) option if timing for commercialization requires fast action that does not allow for reasonable time frame for a construction project.
Finally, this is where a partner, provided they come on board 9-12 months before going commercial, can be of tremendous value. BPs typically run at 70% to 85% manufacturing capacity, and have large staff to handle expedited projects. A timely partner will take the financial burden of dilution away and be able to drive faster outcomes to support manufacturing expansion.
Here's to hoping Peregrine leadership loses sleep at night due to lack of Bavi manufacturing capacity based on sales projections!
Best,
MH
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