Debt is not important in this case because it is not coming due for a long time.
There is still a chance, especially if the company submits a modified NDA. I listened through the webcast and I think that most of the panelists (who are not members of the FDA) were incompetent. One of them even asked what she was supposed to do.
It went something like:
Female panelist: "What are we doing here?"
FDA speaker: "You should be deciding whether the safety and efficacy that we currently see merits an approval decision now, or whether it should be moved back for 2 years."
Female panelist: "But what is your opinion?"
FDA speaker: "It's your decision." (despite that, the FDA speaker inappropriately inserted an opinion in the very last sentence of her presentation)
Female panelist: "Oh, okay."
Panelists completely incompetent. Didn't listen to the presentation and didn't read the briefing docs
Well, a lot of former billion+ dollar companies from 2015 collapsed like this. IDK man but I do not think they lied. I think they had unconfirmed responses and thought that would go through. I think there is still a lot of clarification needed on that. Some of the unconfirmed responses failed to convert simply because of brain metastasis. The company likely picked a very difficult-to-treat population.
Further, taking all evaluable responses only, you have a combined 80% complete/partial response and stable disease rate versus about 85% for Tagrisso (according to AZN's mid-2015 paper and current roci results). (76% roci vs 84% Tagrisso as a % of total)
Rucaparib has all the things possible to make submission as fast as possible. Accelerated approval, priority review, and breakthrough therapy.
They have an upcoming drug that can save the day for investors and is the basis of most analysts' valuations -- rucaparib, an ovarian cancer drug with a current partial or complete response rate of something like 86%.
FDA has not made a final determination yet, and if the FDA reviewers think the same was as the panelists, that would have an effect...
One thing is for sure. After reading 180-some pages of briefing docs, I can say with certainty that the panelists did not.
The one thing that CLVS might have against AZN is that AZN has a 10-times higher rate of resistance mutations (making its drug useless to the patient).