ONC/Y and the FDALike most, I am concerned about both the complete lack of info on potential buyout offers and the expiry of Pfizer's 90-day exclusivity period on Bracelet-1. The lack of info is understandable given the need for confidentiality in negotiations; the exclusivity period expiry is a bit more troubling.
I'm wondering if the "radio silence" is due to ongoing talks with the FDA. Given that Pela has been given fast-track designation for two indications and that there have been no serious adverse reactions to Pela after hundreds of doses given, the two treatment combos (for BC and Pancreatic Cancers) should be excellent candidates for Accelerated Approvals. It is certain that ONC/Y is in talks with the FDA about the design of the trials; it is highly likely they are discussing the trial designs assuming an AA would be granted for one or both indications.
If this were the case, ONC/Y would likely be delaying negos (or at least decisions) on buyouts. An AA for either indication would provide the cash flow necessary for both Phase III trials without the need for dilution or capital injection from a partner (buyout or otherwise). This would avoid the buyout price "haircut" due to ongoing risk in purchase of a company which hasn't gone beyond Phase II yet. In other words, getting an AA is preferable to a buyout and ONC/Y may be proceeding on that basis.