A non-disclosure agreement might keep IPIX quiet about the status of their BTD application, so might an understandable reluctance on IPIX's part to fess up that their BTD was rejected when their share price already can't break a wind. My swag is it's something different, and my swag is it might have something to do with this, from the 7/17 PR announcing IPIX's collaboration with CoreRx: "Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy."
Are sachets exactly the right way to market Brilacidin for an OM indication, so potential OM patients can mix them and use them at home? Yup. Does CoreRx have lots of experience putting dry powdered drugs into sachets? Yup. Is this the way the drug was packaged, mixed, and administered in the pertinent trial? Nope. I don't know the primary packaging used to ship Brilacidin to the clinical sites, but I'm guessing it wasn't a sachet substrate. I do know the drug was mixed with USP water (aka "water for injection") at the trial sites, and likely measured and mixed by a pharmacist or a caregiver.
If I'm the FDA, given the 7/17 news, here's what I'd want to know:
- results of accelerated and long-term stability testing of B granules packaged in the selected sachet substrate, meaning what do the sachet substrate and its contents do to each other if they're sitting on a FedEx trailer in Arizona for 36 hours at 150 degree ambient, or a Seattle warehouse in high humidity for 26 weeks
- what is the air permeability rating of the substrate, and does B efficacy degrade in extended air exposure
- does the selected substrate have any history of delamination, discoloration, or other adverse reactions
- what happens if Brilacidin is mixed into particularly hard or soft chlorinated tap water, instead of USP water
- what happens if some idiot drunk and blind with pain mixes up 9mg/ml instead of 3, and swishes and swallows it
The milestone agreement that included BTD for B-OM as a source of funding was announced on 6/28, three weeks before the CoreRx PR, but the landscape apparently and obviously changed soon after. I think sachets is and will be the right, most lucrative way to go for B-OM. And like more than once in IPIX's record - P3 ABSSSI or bust! - not taking the most direct route to commercialization has proven a test of shareholder patience.
But lordy at the shares I bought today.
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