Biotech Values

[mcbio]

PGNX - 2Q12 CC notes

1. Really bugs me that PGNX doesn't offer any more color at all on the contents of the CRL and I take that as a bad sign. They just stated in the call that they're not able to comment on the nature of the data that the FDA has requested. Why are they afraid to provide some more detail? Management did state later on during Q&A vaguely that the CRL deals with the info the FDA requested at the end of the original PDUFA date.

2. Management stated that in future discussions with the FDA they want to: (a) better understand the FDA's concerns; (b) suggest alternative ways of dealing with the FDA's concerns; and (c) discuss the clinical path and possible designs.

3. It is the same active molecule in subQ Relistor and oral Relistor so management sees the issues involving the subQ and oral formulations as "interconnected."

4. The PSMA ADC has reached a MTD dose of 2.5 mg/kg in the Phase 1 trial, which PGNX expects to complete soon. No buzz at all on the efficacy results they are seeing. PGNX expects to start a Phase 2 open-label trial in 75 patients by the end of this quarter and the trial will take 15-18 months to complete.