If anyone's watching this company, it should make a big move soon, probably in November as they announce the results of 92 events in the PACT Trial.
As I see it, the only way the stock stays where it is would be for approval to be questionable. To me the only question is how long will it take. While I don't expect the improvement over the prior eight month advantage the drug had to fall to 3 to 4 months, if it did it might mean the trial would need to go all the way to 276 events. There are currently roughly 200 people in the trial, if you allowed 8 months to enroll eighty more patients, and 16 months for the last of the 276 to die, you'd need 24 months to achieve the 276th event. IE the trial could end before the end of 2010 with Approval in 2011.
5 months differential might be questionable for approval at 92 events, but should be worthy of a try and if not approved at 92, certainly worthy at 184 events, probably late next year. In part, what the SOC does may determine just how impressive 5 months differential is. The company's told us the SOC will be somewhere in the range of 9 to 11 months, now if it's 9 to 10 months a 5 month differential represents 50% or greater improvement, I believe that's enough to get FDA consideration, but you never know what the FDA will do.
6 months or more certainly gets us better than 50% even if the SOC is 11 months, clearly worthy of approaching the FDA.
I really believe TNFerade has done no worse than 6 months, i.e. 17 months if the SOC remained 11 months, but if the SOC slipped to 10 or 9, TNFerade should be at least 18 to 19 months, and perhaps more. It's very possible TNFerade is doubling, or nearly doubling the lives on average, and even more importantly, with the addition of surgery, some may be in complete remission. We know of one who's cancer was surgically removed and found to be necrotic, there may be more. I don't know how the patients in this catagory are counted, clearly they could add years to the average life span as they may live normal lives.
Bottom line, I believe the chance are nearly even of an approval based on 92 events, and better than even the company will try. Before that occurs I believe the company will make good on its plan to partner the drug for Overseas, keeping the U.S. for itself, this too would be very positive, and should bring in hundreds of millions as a minimum.
If anyone's still reading what's posted on SI, I hope you'll contribute your thoughts as well. I don't know how you go about putting the stock symbol on the listing, if anyone does, you might try to do that so it's more easily found.
Gary |
