- CLVS is just one of very many small biotech companies trying to survive with a poor management.
- Yes, CLVS has just one drug-candidate potentially close to a regulatory approval. Many biotech have none.
- As CLVS's situation stands now, if Ruca clinical results are good then one can talk about a partnership, etc., In any situation, CLVS's management is incapable of successfully marketing a high profile drug.
- This week is quite critical to CLVS: the completion of Ruca applications and a FDA Roci CRL.
The Roci FDA response is well known/expected. It is a CRL. Roci will be rejected by FDA. As for Roci, the investment community likes to know likes to know the Rocu clinical results. Are they good or just marginal? In other word, is there any future for CLVS?
The major problems:
- With 51 pts is that there is not enough pts to speak of statistically reliable number.
- pts observation cut off time was too short to understand of what was going on. The management was in such rush to file NDA ASAP instead of collecting and analyzing data
The summary: Roci may be a promising drug but CLVS present management is P0S
In the latest issue of NEJM,the authors of the original paper published in NEJM in March 2015 claiming Roci ORR=59% published the latest updated Roci ORR results
- The original ORR=59% was based up on too few patients
- The latest Roci ORR is 45% instead of ~30% stated in CLVS's Nov. 2015 press-release
- Even today, the real ORR is not mature to make the final statement
It appears that CLVS were in such rush that they lost their heads.
CLVS mgmt. has made a right decision.
- Roci is now back to square one. CLVS collected and still is collected lots of data on Roci PFS, OS, AE, and potentially most responding subgroups. The present Roci trials were in support of an anticipated FDA approval. With no approval, there is no need for these trials
- CLVS was in a rush to submit Roci applications even before they had ALL required for a submission data. The gamble did not work.
- If Ruca data as good as they previously reported (15-18% complete responses in ovarian cancer), Ruca will be approved with stock going to $50+
- Today the management made it clear that their dream to do everything by themselves is over and they are open to partnerships and even an acquisition.
In other word, the CLVS Roci application got RTF from FDA. Roci is now at a square one: to be approved as a monotherapy it will have to run a trial against the AZN approved drug and show its superiority. The sooner CLVS management understands it the better.
Roci's Tiger clinical trials are a waste of time and money and they are going to nowhere.