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Staples, Inc. Message Board

gswkool 53 posts  |  Last Activity: 15 hours ago Member since: Jan 2, 2012
  • Reply to

    FDA approval

    by gametheorynow Sep 19, 2014 3:09 PM

    If you don't already have substantial profits to protect in PSDV, options are a smart way to play it. Anyone can guess what FDA will do - no one knows what they will decide. I wouldn't know what odds to put on it - . Last time i looked at options they were expensive, so I opted not to protect my position. And then they got denied. It tanked. Then it came back some after FDA agreed to review again for a more limited subset of population i.e. those unresponsive to other treatments. Just wondering what you paid for the options?

  • Reply to

    Any Guesses to whas going on?

    by aussiefrank55 Sep 15, 2014 5:04 PM
    gswkool gswkool Sep 15, 2014 7:48 PM Flag

    If it was a done deal then wouldn't you expect it to be baked into the share price? If that were the case, the shares will really crater if it's rejected. Personally, I don't think that. The FDA will deliberate the benefits of Lluvien for the sub-pop of patients that do not sufficiently respond to other treatments. If there is enough of a clinical benefit, it will be approved. As for the FDA's behavior, you can see by your own description of events how "fickle" they are. So I just try to mentally prepare myself as best as I can for the outcome by not over thinking things. Just gotta sit back and let it happen......

  • Reply to

    Any Guesses to whas going on?

    by aussiefrank55 Sep 15, 2014 5:04 PM
    gswkool gswkool Sep 15, 2014 5:23 PM Flag

    I go by my gut with my investments and right now I'm kind of queasy. If it was a done deal they would have approved it already. My gut says deliberations will commence on the 26th.....I don't know what the outcome will be...I won't even put odds on it....who knows what or how the FDA thinks any more...it's a crapshoot....

  • Reply to

    Shorts Trying To Rock The Boat

    by mickmack50 Sep 15, 2014 9:48 AM
    gswkool gswkool Sep 15, 2014 11:45 AM Flag

    "ILUVIEN, our lead licensed product, is an injectable, sustained-release micro-insert that provides treatment over a period of up to three years of vision impairment associated with chronic DME. ILUVIEN is licensed to Alimera, and we are entitled to 20% of the net profits (as defined) from Alimera's sales of ILUVIEN measured on a quarter-by-quarter and country-by-country basis. Alimera may recover 20% of previously incurred and unapplied net losses (as defined) for commercialization of each product in a country, but only by an offset of up to 4% of the net profits earned in that country each quarter, reducing the Company's net profit share to 16% in each country until those net losses are recouped." - It's complicated -seems like you're right - but ALIM still needs to make a profit "as defined" in a given country before PSDV gets a cut....

  • Reply to

    Shorts Trying To Rock The Boat

    by mickmack50 Sep 15, 2014 9:48 AM
    gswkool gswkool Sep 15, 2014 11:30 AM Flag

    that was not my understanding -perhaps someone else could weigh in on this. I was pretty sure that wasn't the fact...

  • Reply to

    Shorts Trying To Rock The Boat

    by mickmack50 Sep 15, 2014 9:48 AM
    gswkool gswkool Sep 15, 2014 10:16 AM Flag

    there is no revenue stream coming to psdv until alim recoups costs on a country by country basis. it could be some time before they get any money out of EU for Lluvien. On other hand, US is big market - the size of all Europe - so they will get $ from US before they get anything out of EU {upon approval - my guess, anyway}. PSDV will drop under $4 without US approval - no doubt in my mind. The negative price action could just be jitters. People burned before. Or it could mean someone knows something....I hate this......

  • gswkool gswkool Sep 13, 2014 12:39 PM Flag

    Thank you all for your responses. Appreciate the explanations -they were interesting reads. Still holding my shares and patient. .......GLTA

  • gswkool gswkool Sep 12, 2014 6:12 PM Flag

    It's nice that you are getting a response. I would have asked them why they think it turned out that applying their drug later rather than earlier produced better results. That makes no sense to me and throws up a red flag. Perhaps there is an explanation - other than that the drug had no real effect - I'd like to hear it if there is one. ..............

  • Reply to

    September 26 FDA decision

    by sbwill13 Sep 10, 2014 9:13 PM
    gswkool gswkool Sep 12, 2014 12:58 PM Flag

    Looks like there will not be a run-up in the stock price prior to FDA decision - I guess too many have been burnt and sentiment concerning approval may actually be neutral to negative {not that it has any bearing on FDA decision} ......GLTA

  • gswkool gswkool Sep 10, 2014 2:23 PM Flag

    I read that news in my brokerage too, but not the last stmt "Early-treatment cohort.........." -I'm waiting for the presentation to be posted. So delayed treatment is better than either early treatment or placebo? Am I understanding this correctly? They are saying "appears better" - I somehow wonder how this will pan out with more extensive trials. Sounds like a bust to me....I think I gambled wrongly on this one.....

  • Reply to

    my biggest loser so far

    by gswkool Sep 1, 2014 12:19 PM
    gswkool gswkool Sep 8, 2014 8:40 PM Flag

    You're lucky to be on the sidelines. IMO it looks like it's bottomed or close to it. Still, I don't hold it in a vacuum. I have plenty of biotechs to offset this loss. ...GLTA

  • Reply to

    Reasons why RXI-109 Phase 2 will be good!

    by biotechpicklist Sep 5, 2014 10:18 PM
    gswkool gswkool Sep 5, 2014 11:08 PM Flag

    "Dr. Cauwenbergh will provide a corporate update which will include data on novel targets and compounds in the Company's dermatology franchise as well as provide interim data for their first Phase 2a trial RXI-109-1301" - does it make any sense for him to get up there and present lousy results? Does this imply that he knows they are good ? - or is he gonna not bother to present them if they are bad? I don't think someone sticks their neck out there and says they are going to present the data unless they know they are going to be good........what am i missing?.

  • Reply to

    What's Up?

    by kbsmith17 Aug 30, 2014 1:13 PM
    gswkool gswkool Sep 5, 2014 10:53 PM Flag

    it's yogurt power - that side of business will eclipse chocolate bus. .... and we will be up to our #$%$ in $$$$$$$ ....wishful thinking, anyway...

  • gswkool gswkool Sep 5, 2014 10:50 PM Flag

    I don't think it will be around in 2020 - it will be bought out before then.......

  • is BLRX. I bought more on way down and I am now out of the money on all my purchases. Not pleased, but that's biotech investing for you. I still see value in their drug candidates, and I am very patient. Timing is everything. Unless they do another capital raise at this low share price, I think the stock has bottomed at this point. I'm willing to give it more time.....GLTA

  • Reply to

    I Switched Part Of My Geron Holding To ACTCD

    by mruyog Aug 29, 2014 3:37 PM
    gswkool gswkool Sep 1, 2014 11:47 AM Flag

    I own shares in both companies. I bought ACTC cheaply and I have small profit so far. ACTC market cap of 200M+ has held up while valuations of other stem cell companies have been going south. I don't know what will ultimately happen, but they seem to be on the right track. As for GERN, I can only hope Dr. T is able to overcome the inept mgmt at GERN and do for Imeltestat what he was able to do at Mayo -get the hold lifted....not an easy task but we'll see.......

  • gswkool gswkool Aug 30, 2014 1:57 PM Flag

    it's cheap because the platform is unproven and it appears to be a fringe player in the space it is playing in. Positive results in a large trial will have significant impact on share price and enable the company to raise money more cheaply. Negative results and its goose is cooked....IMHO....GLTA

  • Reply to

    PDUFA on Sept. 26

    by yoda_camel Aug 27, 2014 9:45 AM
    gswkool gswkool Aug 27, 2014 12:42 PM Flag

    if it was a done deal they would have approved it already. I think the fda needs to evaluate the updated data package which includes data out of Europe. my guess is they will deliberate on the 26th and we will get a determination then.....just my guess....I won't put any odds on whether its approved or not....I will say that I am a stock holder in psdv shares..............

  • gswkool gswkool Aug 24, 2014 6:52 PM Flag

    FDA has to weigh risk/benefit. Since it is a treatment of last resort, it is not competing with the anti-VEGF drugs approved by FDA. As there is some % of patients that do not respond to anti-VEGF drugs, as long as Lluvien shows some benefit in the data submitted I think it has a decent shot at approval. Not sure what I would do as an investor in the stock if it was denied. If it is approved, I will wait 'til the price settles down and probably buy more shares. Personally, got a good feeling about PSDV but one never knows....don't buy what you can't afford to lose.......GLTA

  • gswkool gswkool Aug 11, 2014 9:39 PM Flag

    the problem in my impression is that it was not in as good hands with GERN. Otherwise, they would be in a better position to satisfy the FDA. Mayo and DR.T was able to satisfy FDA. Certainly it is good that he is gonna be coordinating things. However, he has the task of collecting data which GERN should have been tracking in first place, and it may not be possible to put humpty dumpty back together again. As a shareholder, I hope he succeeds. Otherwise my money is down the toilet. My confidence is not so high, even with Dr. T's help. We'll see.....

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