Franca, see the document:
"Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics" published as an update May 2014... There are special considerations that apply to accelerated approval, and data suggests BRAFi monotherapy w/ Vemurafenib has enabled a less effective follow-up when followed by combo V&C (the combination is actually less effective in the wake of prior BRAFi treatment.) I think there may be a shot at early approval with a rolling review, and Roche has experience with this type of filing. I expect the NCCN will soon address this issue, and an ADCOM would likely result to work through the details of the complicated rolling review process. Keep up the good work...
You send out a lot of unnecessary negative waves. I do agree with you on some points such as carnival barkers at times. You often seem to be the yang to the yin.
Occasionly, you have something good to say. One never knows where gold will come from.
For example, I love your pick of GGB based on "financials" but I know it's not time and outlined reasons for that. Similar analysis led be to point to $1.29 for this stock which I hit exactly on the head. The big buys came in at $1.29 but opened at $1.28 the next day to climb.(yeah, I'm bragging here). You come here and beat down on EXEL but I know your GGB has only gone down when you predicted it'd go up.
You get it wrong somethings because you're only partially right. A metered approach would be beneficial. Why ruffle the feathers?
I dont believe that Breakthrough Therapy will be granted bec its too similar to the gsk combo ... but fast track is history and maybe Priority Review will also be given. What is the earliest date for approval in the US?
market capitalization. And melanoma is only the beginning. And if Cabo (up to now tested in 64 clinical trials) will also be successful as cobi itll be momore r than a 10 bagger.
2nd approval of Cobi/vemurafenib in Europe in September 2015 (maybe later)
Switzerland, Russia, China, Brasil, Australia, Canada and Mexico will follow in 2016
TNBC represents 10%–20% of invasive breast cancers and has been associated with African-American race, deprivation status, younger age at diagnosis, more advanced disease stage, higher grade, high mitotic indices, family history of breast cancer and BRCA1 mutations.
Temporary Assignment --
• Provides regulatory guidance to project teams regarding clinical, nonclinical and CMC submission requirements.
• Manages the preparation, submission and maintenance of US and Canadian Regulatory applications, including routine amendments, annual reports, and correspondence to FDA and Health Canada
• Works with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions
• Coordinates the completion of IND and NDA safety reports and follow-up safety reports and ensure reports are complete and compliant with all applicable US regulations
• Typically requires a minimum of twelve years of related experience and/or combination of experience and education/training
• Minimum of six years overall experience in the biopharmaceutical/biotech industry and at least five years of direct experience in a Regulatory Affairs function
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but I dont believe as a single drug rather together with a cytostatic one in combo. But what other drug will be used? It cannot be Herceptin because of the missing receptor, maybe a taxane as a mitose inhibitor (Docetaxel) or a Platin derivative as a Alkylating antineoplastic agent eg Cisplatin, Carboplatin, Oxaliplatin. Time will tell!
Interesting bet. 10 trading days. You're on!
Sentiment: Strong Sell
Since this is not the first time you have mentioned something like this, I will offer you a bet as well.
I will bet that your sub $1 by 1/1/15 does not occur. If it does I will not post on this board again. If not, you and ALL of your aliases will not post on this board again. Deal?
I have been civil to you, so please respond in kind.