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oneotherfool

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  • Navidea Biopharmaceuticals Is Vastly Undervalued [View article]
    longimgn,

    If you don't mind, I will try to think of some good questions and send them your way tonight.
    Sep 1, 2015. 03:43 PM | Likes Like |Link to Comment
  • FDA eases stopping rule criteria for Sunshine Heart's C-Pulse trial; shares up 14% [View news story]
    Douglas, I appreciate the edit. Sorry, I'm really not trying to be a pain. It's still not 100% correct, but it's better than before. Hopefully, Sunshine Heart actually corrects the data on the clinical trials website.

    Just for what it's worth, late 2016, they will have "enough patients" but not fully enrolled. Please see below for the May earning call transcript. They brought Kim in on the call, specifically to answer this question. She said they expect to have 190 patients enrolled for the interium analysis (not the full 388). They expect to finish enrolling the full 388 somewhere in 2017.

    Here's the link:
    http://bit.ly/1FdP8B3

    Here's the direct quote from Kim.

    "Kimberly Oleson - Senior Vice President, Clinical Affairs
    Hi good morning. This is Oleson. Okay perfect the question that was asked the general concept of interim analysis. And remember the interim analysis is to design to look at about cohort which is 190 for randomize option which have been powered for 12 months of June plan. So as that point of time in the study we’ll just be preparing primary at the end point three good forms of control and then evaluating on our more rigorous statically threshold whether or not we [indiscernible]. The choice to get to that 12 months is pretty [indiscernible] we ensure the design and the assumptions that we need, and I am very excited that FDA grants us approval to move forward with this study."
    Aug 31, 2015. 08:43 PM | Likes Like |Link to Comment
  • FDA eases stopping rule criteria for Sunshine Heart's C-Pulse trial; shares up 14% [View news story]
    well, this is where you get into what do they mean by "primary outcome measure"... Not sure how familiar you are with $SSH but they've requested that they do an interim analysis (which, they got approved for early this year by the FDA). So was the "primary outcome measured" meant for the interim analysis, or this is what they had initially for the study?

    Bottom line is, again, it's simply not true that they will have 388 patients will be fully enrolled by that date. This was explicitly communicated to investors, by management. As you can see above, I acknowledge the fact that clinical-trial website would need to be reviewed for accuracy.
    Aug 31, 2015. 07:33 PM | Likes Like |Link to Comment
  • FDA eases stopping rule criteria for Sunshine Heart's C-Pulse trial; shares up 14% [View news story]
    Douglas,

    I agree that it needs to be checked. However, with all due respect, there's nothing there that says the 388 patients will be fully enrolled by that date.

    What it says is "April 2016 (Final data collection date for primary outcome measure)"

    Furthermore, what they have there is "unclear" to say the least. I provided evidence as to why it's wrong, form the CEO's own words.
    Aug 31, 2015. 12:47 PM | 1 Like Like |Link to Comment
  • FDA eases stopping rule criteria for Sunshine Heart's C-Pulse trial; shares up 14% [View news story]
    Posts like that need to be fact-checked. This way, you're setting un-realistic expectation for investors. There's just no way they would complete enrollment of 388 by March. Especially with the FDA enrollment pause that's happened.

    The interim analysis is something that is expected in 2016, but not with fully enrolled study. PLUS, that's the end of 2016 and not in March, per the above quote.

    Aug 31, 2015. 11:50 AM | Likes Like |Link to Comment
  • FDA eases stopping rule criteria for Sunshine Heart's C-Pulse trial; shares up 14% [View news story]
    Douglas,

    "The final data collection date for COUNTER HF, with an estimated enrollment of 388 subjects, is April 2016."

    This is just simply not true. Where did you get that information from? Can you please link us?

    Here's an answer from Dave Rosa during the last earning call.

    "Yeah, so really the next big data point for us is the interim analysis which we think that we’ll have enough patients for the interim analysis late next year. We previously communicated that by end of 2016 we would expect having enrolled enough patients to do that. Now, there is - we want to be conservative with this because this trial - getting Class III heart failure patients to enroll has taken us longer than what our original schedules had shown. That being said, we see a lot of the obstacles are behind us and the piece moving forward is to really get these patients, the pipeline of patients we have to agree to do this. As we add more centers, those numbers could change, it could get better, but I’m really encouraged, I know Molly is, I know her team is based on what we’re seeing. So - but that’s more or less what we’ve modeled into our plan that indicates your inflexion point."
    Aug 31, 2015. 11:45 AM | Likes Like |Link to Comment
  • On the hour [View news story]
    Averages are not paring anything....back up we go :)
    Aug 27, 2015. 03:52 PM | Likes Like |Link to Comment
  • LeapFrog: Bad News At Any Price? [View article]
    Oky, in case the links above were not working. Check this one.

    http://bit.ly/1UYGqzR

    Look for "buy" under "transaction type". There were a total of 4 in November.

    By going to the Nasdaq website I link above or going through the company's website, you should be able to find anything.
    Aug 21, 2015. 07:35 PM | Likes Like |Link to Comment
  • LeapFrog: Bad News At Any Price? [View article]
    South, did you check the links I provided? They were open market purchases.
    Aug 21, 2015. 04:16 PM | Likes Like |Link to Comment
  • LeapFrog: Bad News At Any Price? [View article]
    Not true...They did buy in the $4s prior to Q4 results, as I said above.

    Here are some form 4s...take a look:

    1. http://bit.ly/1PDqvDP

    2. http://bit.ly/1PDqvDR

    3. http://bit.ly/1PDqwrC
    Aug 21, 2015. 10:30 AM | Likes Like |Link to Comment
  • LeapFrog: Bad News At Any Price? [View article]
    They couldn't have gotten it more wrong, than they did in that 4Q. It was absolutely horrendous/disaster/te... (can't find proper adjective-insert your own).
    Aug 21, 2015. 07:46 AM | Likes Like |Link to Comment
  • LeapFrog: Bad News At Any Price? [View article]
    What baffles me is that they did buy, not so long ago in the $4s. ( yes that is 400% away, but believe or not it wasn't too long ago)...point is, I'm surprised they are not buying here....could be because of the lawsuits that was brought on the company post to Q4 results.
    Aug 20, 2015. 11:00 PM | Likes Like |Link to Comment
  • Einhorn takes positions in HTZ, OI, KORS, UIL [View news story]
    BK_h, when you say "x% down since", what do you mean by that? Do you mean they're down since he took a position? How is it that $KORS is down "23% since", if the position is just announced? Can you clarify?
    Aug 14, 2015. 07:13 PM | 3 Likes Like |Link to Comment
  • WidePoint Corporation: Will It Double? [View article]
    Johnathan,

    Without reading the article. I just wanted to answer your question (title). The answer is YES :)

    I will now proceed to reading it.
    Aug 14, 2015. 01:58 PM | 1 Like Like |Link to Comment
  • Arena's Smoking Cessation Opportunity [View article]
    True. Not sure I follow what you mean. Let me clarify, in my first conspiracy theory, I'm saying that if Eisai is shopping around the smoking part of belviq, then they're probably shopping around Belviq altogether. It wouldn't make sense to keep the un-successful weight loss. In my second theory, I meant partnerships for the likes of APD334.
    Aug 12, 2015. 05:17 PM | Likes Like |Link to Comment
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