Thanks Caly,
Hopefully this board will attract more attention than the others and we can get real discussions going here.
In the next 3 months I expect GNVC to be the subject of a lot of discussions as first we get the top line on the PACT Trial and finally early in June we get as much of the trial data they're willing to share from an ASCO Poster Presentation.
What's unknown is when, or if GNVC will establish a partnership before Approval is actually obtained. They're currently positioned to take TNFerade to approval without a partner, this greatly enhances their ability to get a partner on terms closer to what they want. They will need to address manufacturing the drug, and if no partnership occurs shortly after the data become available, I believe they'll either re-establish the contract with Cobra, or find another contract manufacturer, perhaps a potential partner, that can get the job done in a year or less.
I believe TNFerade faces roughly four scenarios which should lead to approval, sooner or later.
1. They meet the Stat Sig requirements for approval at 184 events and submit a BLA to go for it.
2. They just miss Stat Sig 184 event requirements, but with the recommendation of the DSMB go for approval based on both the values they did make and Secondary Endpoint data which could put them over the top.
3. They complete the trial and meet the penalized P-value they agreed to and they submit a BLA.
4. They fail to meet the established P-value, but have a P-value which would gain approval for most drugs. They submit a BLA with full documentation of benefits from secondary endpoints. They either gain approval, or they're told what additional trials, data, etc. must be submitted to gain approval.
If I remember correctly, most drugs in larger trials gain approval with a P-value of .050, but because GNVC held cost down with a smaller or single trial, they started with a P-value of .025. GNVC wanted some peeks at the data, that came with further penalties, so now they're at something slightly below .02 as I remember it. It's my belief that anything under .05 warrants discussions with the FDA which will come from the submission of a BLA, though their may be other ways of bringing them about.
Gary |
