This is the meeting that they nail down P3 design and they stated in the CC that there are two different avenues for trial design depending on the PARTNERS preference. Just read between the lines on that statement during Q&A
Mostly depends on the upfront payment and on how they will split the rights in the different Countries...let's wait and see...NBIX seems well positioned and with strong data to attract a bidding competition for a partner IMO...
I too, agree...however, when is this meeting scheduled?
Also, we have to see if the partner will be for NAmerica only or Europe, too.
In this case, how much of upfron milestones will NBIX receive? I believe no lower than 100M dollars IMO, that would be around 2$ a share in cash (plus the already have up of 60M in cash). Also we have to wait at the end of august to see how GSK trial will go (if positive, isn't a 75M $ payment due to NBIX)?
After partnership NBIX could trade at 2 to 3 times cash (around 6 to 9$) and if GSK gives good news, NBIX price could exceed 10+ dollars per share. Who agrees on this?
This is just my opinion of course.
Nice post. Sounds sensible enough. Same for mr Frogleap. Turns out, didn't even need to read between the lines that much (quote at the bottom of the post, taken from the CC transcript, courtesy of Seeking Alpha) (emphasis added). They certainly expect a partnership of some sort before they start phase 3.
As I posted before, I can only dream they can secure a deal like Acorda did with Biogen. Share priced dropped a little at the time, because everyone was in buyout speculation frenzy, but it was awesome deal - I bought that dip and made a very tasty profit. For those that didn't see that deal, it was 100 million bucks upfront. 400 million in milestones, and double digit (they didn't say quite how much) for non-US sales. Plus further royalties on future "combination" therapies using Ampyra with Biogen's existing products. Acorda kept the US sales exclusively for themselves.
As for the quote:
"Our plan, once we have the 901 data in hand, we will then integrate that information into the end of Phase II data package, and then we formally will request an end of Phase II meeting from the FDA. That request will go in a few weeks after we've gotten the 901 data, so let's say late June, and then that's a 60-day clock for that type of meeting. So that would mean that at the FDA's discretion, sometime between mid-August and early September, they will hopefully grant us a meeting date at which time we can review our data package and ask if the division indeed concurs that we can move forward into a Phase III program.
At the same time, in parallel with the end of Phase II meeting request and data submission package, we will submit the proposed protocol for the Phase III study in the form of a special protocol assessment, and that will be reviewed. And most of the time, an FPA takes two turns of the crank if you will. The timing of the review and a response overlaps for the end of phase II. So we don’t have exact dates on that. Again, it depends on the FDA. We should end up with a response around the same time that we have completed the end of Phase II meeting, ***which puts us in a good position to be able to initiate Phase III trials toward the end of the year, given that we have our partnership in place***.
As Kevin had said before, ****we want to be ready to start, but we will not be starting thephase III trial without that partnership agreement in place***. So that program is moving along very nicely. We understand a lot about this molecule. We've worked through some changes from the FDA as we started our phase II programs with a monthly recall scale, the same scales that were used to approve all the other endometriosis drugs. We were then asked to use a daily scale with the FDA wording that they gave us, ran into a very nice result with dysmenorrhea but a hiccup on non-menstrual pain. We think we fixed that problem; we're confirming that with the 901 data. That's our expectation that we will confirm that with the 901 data, and that will put us in a good position to request the end of phase II meeting this summer.
The end of P2 meeting with the FDA is in reality the trial design meeting for P3. Big Pharma partner is going to want significant input at this meeting based on their internal expertise. So IMO, they will have a partner within the next 60 Days.
They have been doing DD with potential partners for at least 2 years, so discussiona are near the end point, its all about how big the check is going to be, end of story.