Guess that the 'news' did not impress Wall Street. Currently the shares are down $2.25. cheers
Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer. This is two weeks earlier than Clovis indicated earlier. The process should be completed by the end of July according to the press release.
"Clovis Oncology, Inc. (CLVS) announced today that Dr. Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, has been named Chief Medical Officer and Executive Vice President of Clinical and Preclinical Development and Pharmacovigilance, to become effective in early August. Dr. Rolfe succeeds Dr. Andrew Allen, who will be stepping down from his role at Clovis at that time...... Dr. Rolfe joined Clovis in early 2010 and oversees rociletinib and rucaparib development in her current role as Senior Vice President of Clinical Development."
Thanks for keeping it real sreal :). If it hold true market is then significantly discounting Clovis. I'm a happy long either way.
Any talk about their third drug (FGF inhibitor?)
Didn't say they cannot do that. But, there should be more testing required first for a wider population. Otherwise they're not comparing apples to apples. More Asian women get non-small cell lung cancer than Caucasians, which is likely why AZN is doing trials for that population. However, the 2 races also respond differently to the Tx. AZN did not report their latest results, which is curiously odd. As for the market, CLVS has more than doubled in a year. Still has a ways to go. PPS cannot reflect this since nothing is marketed yet. The key word here is 'Patience'. Good things come to those who wait.
Thank you for the update. Seems like market does not agree with Clovis's assessment of data. Are you sure that AZN cannot launch the drug in USA? That should be a very big shot in the arm and I wonder why pps is not reflecting that.
The actual meeting ended in less than 10 minutes, as I was walking in the door, so that was inconsequential. However, I spoke with Investor Relations afterwards. They will likely begin manufacturing at least one of their drugs by the end of this year via outside contractors. We compared results of their Rociletinib for non-small cell lung cancer drug to Astra Zeneca's (AZN). It seems clear that Clovis' is a much better option considering its strong performance with only mild elevated blood sugar in some, compared to the more serious to life-threatening side effects of AZN's, including death. Plus AZN would likely be required to do a study on efficacy on Caucasians before it can enter our market. There is a difference in the both development of the disease and Tx response between Asian's, upon whom AZN's been testing, and Caucasians. At this point it seems that Rocilentinib could quadruple the 2-month life expectancy of the patient to 8 months (and still counting) with only minimal side effects. Trials continue with thus far no termination point as to maximum months of efficacy.
You have got it backwards. Clovis is preparing to submit a NDA for rociletinib, its nsclc drug, in July next. The ovarian cancer drug, rucaparib, will have a NDA submitted about a year from now according to its CEO.
The word 'definitely' is a little strong. If it was definite the stock would be at $115 not $86. That's a 30% difference which, if true, Wall Street would be lapping up the shares. Wall Street can't resist a 30% profit. cheers
CLVS was dismissed as insignificant yesterday at the ASCO conference.....virtually rediculed...Goldman Sachs misled investors again....they shorted as you bought at 100....evil #$%$