I don't know if anyone is still following this thread, but if so, people should realize that data from the PACT Trial is no less then good, perhaps great, already. At 92 events, late last August, there were 95 patients still surviving. At an average rate of 7 per month we've added roughly 95 more in the 13.5 months, but we've still not heard of the 184th event.
It should be clear to all that patients are living well beyond the roughly 9 months mean for the SOC. I suspect that the data will improve dramatically from what had been revealed at 92 events, though simply duplicating it should have proven worthy of approval in time.
If I'm correct, the possibility of filing a BLA on the strength of this data grows with every day. Likewise the need for a partnership increases as the business plan, at least now, requires a partner for manufacturing. Let's be clear, the plan could change, perhaps back to Cobra or some other manufacturer under contract, but as indicated by the company, it will be a partner who ultimately supplies the drug.
GNVC will see the data 2 to 3 months after the 184th event from the DSMB, along with the recommendations of the DSMB. Should the DSMB recommend filing a BLA, or in some other way initiating discussions with the FDA, that could be huge as well.
For now, we wait, and this is truly a case where no news is good news, and it gets better with every day.
Gary |
