CLVS management credibility is the major problem. Now, I and other investors have doubts wether one can trust to CLVS management. During the Q3 conference call, CLVS management hided from investors community the info that FDA did request additional data since the previously submitted data were almost 40% below the results submitted to FDA for the approval process.
The problem is not that data changed since ever Ph2 and Ph3 trials very often fail to meet expectations. The problem is that the management hided these results. The CEO has lost his credibility and cannot be fully trusted. Even if drugs are great, still the CEO is a big problem going forward.
CLVS's Roci is not killed but was injured. CLVS & AZN competition in NSCLC will be determined by success of a combo and this game just started. Note that the AZN combo trial was stopped due to side-effects.
CLVS PAPP in ovarian and other cancer is on. AZN drug was approved in refractory ovarian cancer with AZN, TRSO, and CLVS are moving into 1st and 2nd lines treatment. By the way, TSRO has no oncology drugs approved and their ovarian drug is in Ph 3. TSRO market cap is $2B
In the next 1-2 months, FDA will reveal their intention regarding to Roci. Today , AZN Tagrisso looks superior to Roci in NSCLC but their registration trials were conducted in different patient populations. In the next two-three months, there will be more clarity. Hopefully, CLVS's management learned the lesson from their last fiasco.