1st I want to say thanks to Onebarkmill for the detailed summary.
Known coming milestones(based on dates given in CC):
- CardioPET clinical development report finished - ~2-3 weeks (early to mid July)
- Complete chemistry validation and open enrollment for BFPET P2 trial - "early Q3" (July?)
- Present CardioPET P2 comparative imaging data at ASNC - late Q3 (Sept 23)
- Present CardioPET P2 safety data at EANM in early Q4 (October)
- Meet with FDA regarding bringing CardioPET P2B into the US (2H '16)
(Hopefully) coming milestones (unknown timing):
- Merger/acquisition of Ground Flour Pharma - "coming months" - during CC, they said they likely have a lead investor to consummate the deal
- Money in the bank through a capital raise (or other) to get the financial overhang out of the way and fund the P3/P3 trials of PFPET and CardioPET through commercialization
- More licensing agreements - either with the new GFP tech, or licensing out 1 or both of the the homegrown products to other geographical areas.
If I missed anything, feel free to add.
We have been waiting for this company to get to the execution phase for a long time now. It looks like we just got there, and added a new technology that can provide some near term (albeit mild) revenue and allow us to make PFPET at a yield and scale that allows the commercialization to move forward and (more importantly) be profitable.
At the end of the CC, they said they now have enough $$$$ on hand to get the company through the merger and move the development of both CardioPET and BFPET forward as outlined above.
[18F]MFBG was prepared in almost 3-fold higher yield than previously reported (31% corrected to end of bombardment, n = 9) in a synthesis time of 56 min with 99.9% radiochemical purity. Other than pH adjustment and dilution of the final product, no reformulation was necessary after purification. This method permits the automated production of multidose batches of clinical grade [18F]MFBG. Moreover, if ongoing clinical imaging trials of [18F]MFBG are successful, this methodology is suitable for rapid commercialization and can be easily adapted for use on most commercial automated radiosynthesis equipment.