Considering the announced test results, TSRX seems to be taking its own sweet time with an actual NDA filing. Two possible explanations come to mind:
1) The FDA requires yet more data. Hope not.
2) TSRX is right now looking at major partnerships or negotiating an outright sale. In this scenario, TSRX is more or less telling the world, "We can talk right now for $x or we can talk next fall for $2x, at which point we just might decide to stay independent and you'll be out of luck."
My guess is 2. It's certainly what I want to happen.
Good Luck to All
I guess that option 2 is possible in the interim space. Putting an NDA together for a company not really used to doing it "is basically a 6 month process" if one knows just what is needed for the NDA! They are serious volume submissions of data telling the story of the entire development process of the drug.
The real question is, if TSRX were waiting for these results and they are designed to be confirming the first P3 trial (ya need two P3 to submit), why didn;t they start the shell of the NDA earlier? This leads ya right back to option 2 as an option!
As far as option 1, dont think they need more data for the indications studied gto date. They can submit what they got! They would need more data for expanded indications and they plan another study for just that. That brings up another question---if you are seeking partnership then why start another expensive study, when maybe you could negotiate development cost help pay for this within a theoretical partnership agreement?
If a deal is coming, it would theoretically come in the summer or else this company continues alone thru an FDA decision. IMO. What they have right now is either good enough or not good enough for a deal--by July 4th you will definitively know!
@beavertail_splash - LOL "unplug the Betty Crocker oven unit, move, replug. Viola ready to go"
Uh...hardly. You'll have to have some sort of Change Process Controls to ensure that the manufacturing process is still the same as it was when clinical trials were performed. Especially if the process is to be "scaled up" which I highly expect.
There is still a tough road ahead otherwise Trius would have had a faster timeline on the NDA.
I am not saying the investment here is not good. All I am saying is that I am impatient. I wanted to invest here and see my dollars fly! Seems like we will have to wait a while.
You watch...there is going to be some big announcement about a buyout and I'm going to be sitting here with my cash going...dam it !!
The other thing we got going is the market has tested this "ALL TIME HIGH" like 3 times already. The more times it tests without a breakout, the bigger the fall. If the overall market isn't ready TSRX won't be either. Just a fact of life.
"My bet is they are planning to transfer the commercial manufacturing to another site to prepare for growth. If you have to transfer the manufacturing site you have to perform process validation at the new site" ....what's involved in transferring manufacturing site? Unplug the Betty Crocker oven unit, put it into the box, move, replug. Vola' ready to go. Oh and make sure the 60watt bulb still works.
Not correct, the IND has the entire development process and that happens before clinical trials. They should have the development process copied and pasted into the NDA from the IND submission. The NDA adds information such as process validation studies, stability studies, and your clinical data. This should be easily wrapped up within a month of Phase 3.
Something else is going on here. My bet is they are planning to transfer the commercial manufacturing to another site to prepare for growth. If you have to transfer the manufacturing site you have to perform process validation at the new site.
Under the GAIN ACT the FDA has expedited this process and has become proactive in assisting potential new antibiotic developers through the approval process & paper maze. QIPD designation, given under the Generating Antibiotics Incentives Now (GAIN) Act will help Trius fast track the drug through the FDA process enabling shorter application periods than previously required.