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There seems to be confusion over the P3 trial where people think the company has bad data in hand, based on what they “thought” was a new P3, but we think is actually a supplemental P3b.
The current Phase 3 trial has 270 patients, but this “new” one is 90? Would the FDA accept the results of a 90 patient trial if a drug failed a 270 patient trial? — We don’t think so.
The risk-reward here seems to be better mitigated, and the chart tends to support a bounce back to around $18. Remember, the markets expect to hear data from $ONTX sometime in December.
It’s obvious to us that the company does not know or have the data from the 270 patient trial in hand, and we believe the latest trial is a supplemental 90 patient one, and not a replacement for a failed one.
Onconova expects to present Phase III data for Rigosertib IV in pancreatic cancerin the fourth quarter of 2013 or the first quarter of 2014. The company states:
“We are conducting a multi-center Phase 3 trial of rigosertib IV in combination with gemcitabine, a widely used chemotherapy drug, for the first-line treatment of metastatic pancreatic cancer patients. In March 2013, we completed enrollment of 150 patients in this trial and we expect results of the pre-planned interim analysis for overall survival in the fourth quarter of 2013 or the first quarter of 2014. The American Cancer Society estimates that 45,200 new cases of pancreatic cancer will be diagnosed in the United States in 2013.”
Onconova is under speculation valued at today’s market cap of about $350M. Investors have yet to investigate the value of these results should they be positive, and as mentioned before, the supplemental P3B is just that – supplemental in our view We feel the stock should trade currently in the mid $25 range
