Don't let the sun go down on Sunset just yet Carboat!
Part of preparation for commercialization requires establishing capability across all manufacturing phases with supporting capacity of 18-24 month sales projections from point of approval.
I think many have realized that building capacity and having approval to produce commercial units is anything but a sure bet when it comes to timing and readiness. It's complicated, expensive and fraught with unexpected trouble. One needs to start early, invest and prepare for the starter pistol. Many a company built capacity that ultimately got moth balled due to product not receiving approval or getting delayed. All that is acceptable - but what is not acceptable is receiving approval and not having approved manufacturing capacity to produce.
Notice from the quarterly that some dates are staring to converge on 2017 and 2018. Peregrine is going after the two largest, by far, Oncology indications - focusing on Lung and Breast.
While none of us know (though many pretend) how long (or short) it will take to get there, be assure that the ability to gauge value and align for approval is changing and accelerating - promising shorter trials and faster review/approval cycles, as well as looking for less 'volume' of evidence, while relying on more targeted and specialized evidence.
Provided this all come together for sometime 2017 to very early 2018, and multiple significant indications get approved, it will be a vertical sales curve for Bavi. Manufacturing capacity and reliability will be of utmost criticality and they need to put the time and effort to build it now. They're not done - more is coming and known to some ahead of the recent quarterly.
Finally - Sunrise is very relevant and for a variety of reasons. Focus will be to get approval for Chemo and Checkpoint combos across two or more cancers. There are currently dozens of trials by BPs with chemo and a variety of PDXs and other checkpoint inhibitors as those combos are showing results.
Reliance on a cash sidestream from manufacturing, while keeping one's manufacturing capacity and acumen in sharp shape, is not the same as preparing to become a 'manufacturing' company in case the primary business objective doesn't come through. That's never been the intent and, with recent development, it definitely isn't the trend going forward.
Post Finally... there will be serious cash bleeding until a deal takes place - but it's not based on some random decision making or loose respect for cash burn. From all indications - Peregrine is going ultra aggressive on positioning for the next wave in Oncology evolution by introducing a molecule with broad range combination synergy across treatment modalities. Notice the pre-work with the FDA on trial design for the Breast P II. Notice the early data readouts of less than 12 months from trial start for indications such as Breast that traditionally take 18-24 months. Money will burn and it's for a great cause. They're aiming to come in with an overwhelming set of results that will instantly establish this method of treatment as an anchor.
Big goal and I am rooting for success.
Best,
MH
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