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Affymax, Inc. (AFFY) Message Board

bashers_are_liars 27 posts  |  Last Activity: Apr 29, 2015 8:40 AM Member since: Jan 28, 2009
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  • Reply to

    Fast Track % - Snowflake was wrong...very wrong

    by ulingt Apr 9, 2015 3:34 PM
    bashers_are_liars bashers_are_liars Apr 9, 2015 4:04 PM Flag

    ulingt You just proved you can not rely on everything you read on these message boards, intentional, or unintentional , some people's interpretation of the written word can vary wildly from what is actually written.

    Good job !

  • Reply to

    WHERE DOES EYES TRADE TOMORROW?

    by richheide61 Mar 3, 2015 11:58 PM
    bashers_are_liars bashers_are_liars Mar 4, 2015 1:22 PM Flag

    On the NASDAQ . And I'm not guessing.

  • bashers_are_liars bashers_are_liars Apr 29, 2015 8:40 AM Flag

    sauble.beach Is the Jim Cramer of this message board...............do the complete opposite of what he says to do.

    And he's also a LOUD TALKER ................just like the Cramer guy.

    He's "DOUBLING UP" alright................DOUBLING UP......in PAIN !

  • Reply to

    Question.....

    by robert30 Mar 18, 2015 5:02 PM
    bashers_are_liars bashers_are_liars Mar 18, 2015 8:23 PM Flag

    "...our only saving grace is that volume has dried up markedly! And that's a big plus... "

    On a pullback the diminishing volume is usually the sign that the sellers are about depleted.

    We'll soon see. A lot of people now worldwide are aware of Second Sight because of the recent massive news coverage/publicity.

  • Reply to

    Question.....

    by robert30 Mar 18, 2015 5:02 PM
    bashers_are_liars bashers_are_liars Mar 18, 2015 8:05 PM Flag

    Hey notsobrilliantstorm, you also are doing more than your fair share of wishful thinking .

    Wishing we go back down to $8 so you can get what you missed out on ?

    Practice what you preach !

  • bashers_are_liars by bashers_are_liars Apr 10, 2015 2:00 AM Flag

    Fast Track Designation Request Performance
    The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling review" for an application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

    To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER's performance in reviewing and deciding on these requests.

    Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics - 5/20141; Appendix 2; Appendix 3 - (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.
    --------------------------------------------------------------------------------

    CBER Fast Track Designation Request Performance Report
    All Requests Received
    (March 1, 1998 through March 31, 2015)

    Number Submitted Goal Within Goal Overdue
    Granted Denied Pending Total % Granted Denied Pending Total %
    311* 60 days 189 107 7 303 97 5 2 1 8 3

    Since March 1, 1998 through March 31, 2015, 311 Fast Tracks were requested, 189 were granted, 107 Denied, the rest were pending.

    So EXEL being granted FT says something positive about them.

  • CBER Fast Track Designation Request Performance Report
    All Requests Received
    (March 1, 1998 through March 31, 2015)

    Number Submitted Goal Within Goal Overdue
    Granted Denied Pending Total % Granted Denied Pending Total %

    311* 60 days 189 107 7 303 97 5 2 1 8 3

    *Does not include three requests received by OTRR and pending on October 1, 2003. Final actions on those requests are counted in CDER reports.

    Page Last Updated: 04/08/2015
    Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

    Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies FDA
    U.S. Food and Drug Administration
    10903 New Hampshire Avenue
    Silver Spring, MD 20993
    Ph. 1-888-INFO-FDA (1-888-463-6332)
    Contact FDA

  • Reply to

    Final thoughts on Fast Track

    by ulingt Apr 9, 2015 8:11 PM
    bashers_are_liars bashers_are_liars Apr 10, 2015 10:11 AM Flag

    neers87 The fee is a requirement for all Fast Track designation requests..........but it is no guarantee the designation will be granted.

    You have to have the goods to get the designation............EXEL has the goods.

    Anybody who paints the Fast Track designation approval as a negative is full of something........and the Church Lady at Yahoo won't let me say what they are full of anymore.

    Like in the good old days.

  • Reply to

    BREAK OUT

    by saltydog711 Apr 13, 2015 10:42 AM
    bashers_are_liars bashers_are_liars Apr 13, 2015 12:52 PM Flag

    That could be some very bullish longs, or some very nervous scared shorts covering.

    Both scenarios are bullish for the stock price.

  • Reply to

    Seymour and the Army of Darkness

    by wilderguide Apr 13, 2015 1:29 PM
    bashers_are_liars bashers_are_liars Apr 13, 2015 3:29 PM Flag

    I know one fact, your short is taking a DNA bath, or as they used to call it, a bloodbath.

  • Reply to

    Yep. we'll continue the walkdown tomorrow

    by ahlmidezherioff Mar 5, 2015 6:42 PM
    bashers_are_liars bashers_are_liars Mar 6, 2015 2:15 AM Flag

    Why do you insist on making a complete fool of yourself ?

    You need to get yourself a new writer, someone that can come up with a new one-liner for you other than ......"well continue the walkdown tomorrow".

    Do you even realize how many times you've made this redundant tripe comment on these message boards ?

  • semanresu's....."a golf ball in tall grass" is a start'

    Can somebody else top that one ?

    Sentiment: Strong Buy

  • bashers_are_liars bashers_are_liars Apr 10, 2015 2:11 AM Flag

    Be sure to notice this part at the bottom.

    Since March 1, 1998 through March 31, 2015, 311 Fast Tracks were requested, 189 were granted, 107 Denied, the rest were pending.

    In 17 years a total of 311 Fast Track requests were made, and 189 of them were granted.

  • At today's date there are 189 drugs with Fast Track designation, here is how many Fast Track drugs received FDA Approval as of September 2007, which was 9 years after the Fast Track program started, today it is 17 years after the Fast Track program has started. So as of September 2007...........

    The Plain Dealer's Fast Track Drug Analysis: Drugs Approved
    This list includes 67 drugs identified by the Food and Drug Administration (FDA) and three vaccines that were approved through September 2007 under the special Fast Track designation. Of these, 44 were developed by major drug companies and another five by small biotechs partnered with major firms, according to a Plain Dealer analysis. Another eight were developed by large biotechs. All but three of the 70 products were developed by public companies.

    So now all we have to do is find how many drugs were Fast Track designated as of September 2007 and you can get a pretty good picture of how successful Fast Track designated drugs are at finally getting FDA approved. I think I saw that source month by month , or year by year each of approvals about a half hour ago, but I'm old and I'm going to bed now, and will try and dig that up again tomorrow.

    But if 70 were approved as of September 2007, I'm guessing there were probably only about half of the current 189 were designated Fast Track back then, which puts that percentage track record pretty darn high for approvals, very close to 100%.

    I don't think it is going to take very long for this to sink in with a lot of people......shorts/bashers etc..

  • bashers_are_liars by bashers_are_liars Apr 9, 2015 10:24 AM Flag

    They already know what the results are going to be....." Cabozantinib is the subject of METEOR, an ongoing phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Co expects to release top-line results from the trial in 2Q15."

    Sentiment: Strong Buy

  • bashers_are_liars bashers_are_liars Apr 11, 2015 2:26 AM Flag

    jrobb0613 So what you are saying is that any company can request Fast Track designation, and the FDA will look at what the company has, and no matter what.............they will grant the company Fast Track ?

    Just request it and you will get it ?

    Then can you please explain to me why out of 311 requests for Fast Track..........189 were granted.......and the rest were sent on their way ?

    That does not jibe with your opinion.......at all.

    What is your function in the "biotech industry" ?

  • Reply to

    Rubber meets Road

    by ulingt Apr 13, 2015 8:25 AM
    bashers_are_liars bashers_are_liars Apr 13, 2015 11:52 AM Flag

    A large short position is bullish for the stock price, that action has already taken place, that damage has already been done to the stock price.

    The next action is the bullish one for the stock price..........the covering.

    Any positive news and those short shares have to be covered..........bought and returned to the lender.

    A large short position has a double-whammy affect on the stock price in the event of some very positive event, because at the same exact time you will have new people going long on the stock, and the shorts having to buy the stock to return to lender.

    Any positive events expected in the future ?

  • bashers_are_liars by bashers_are_liars Apr 16, 2015 1:01 AM Flag

    Matt DiLallo owns shares of Chart Industries and has the following options: short January 2016 $32.5 puts on Kinder Morgan and long January 2016 $32.5 calls on Kinder Morgan. The Motley Fool recommends Chart Industries, Clean Energy Fuels, Kinder Morgan, and Westport Innovations. The Motley Fool owns shares of Chart Industries, Kinder Morgan, and Westport Innovations.

  • And they have the capital to do it.

  • bashers_are_liars bashers_are_liars Apr 9, 2015 11:22 AM Flag

    Fast Track is an excellent indicator the FDA likes what they see, and there is an urgent need for the drug .

    Back burner to front burner means let's get this ball rolling.

    They obviously see something they like, or they would just let the normal slow as you go process play out.

    Something lit a fire under them.

    As far as statistics go, putting the drug on Fast Track........is a huge improvement than not on Fast Track.

    Front of the line, or back of the line...........which is better ?

AFFY
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