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  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Since someone finally put up that PK chart, my question is why does it take so long for plasma levels to increase when administration is by IV? Liposomal dox should peak almost immediately, no?

    I'm no PK guy, but makes no sense to me.
    Dec 24 07:52 PM | 3 Likes Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Great job! Unfortunately, no CLSN long will succumb so easily to facts and logic
    Dec 24 07:17 PM | 3 Likes Like |Link to Comment
  • Bullish On Amicus Therapeutics [View article]
    Placebo response was questionably high; something is unexplained here. Guess we will find out at the February conference. Crowley should have put up more of a fight with GSK to have a conference call.

    Nice call by yourself.
    Dec 20 12:19 PM | Likes Like |Link to Comment
  • Bullish On Amicus Therapeutics [View article]
    To be clear, they have not looked at the 6-month data. Company is still blinded to those results.
    Dec 13 10:16 PM | Likes Like |Link to Comment
  • Bullish On Amicus Therapeutics [View article]
    There is no alpha hit. Please explain why you think there would be. We see no reason for it.

    Substantiate your claims if you believe it won't meet the 6-month primary endpoint.
    Dec 12 01:14 AM | Likes Like |Link to Comment
  • Bullish On Amicus Therapeutics [View article]
    Need Amigal to work first. It's also unclear how much better Amigal+ERT vs ERT needs to be for it to gain traction and reimbursement.
    Dec 11 03:02 PM | Likes Like |Link to Comment
  • Bullish On Amicus Therapeutics [View article]
    It was explained quite clearly, you just chose to cherry pick a sentence. If they unblind at 6 months and release the results, it will bias the 12-month data etc. FDA agrees with them.

    "Admittedly, it is somewhat strange that they have not released the 6-month blinded data, while patients in both arms know they are on Amigal. However, the reasoning behind it does make sense. The idea is that if the 6-month data are unblinded, knowledge of results will affect participants in the 6-month extension study. Remember placebo patients are allowed to switch over to the Amigal 6-month extension study. Technically, they don't know if the drug works or not; patients are not told the results of the 6-month data. Hence unblinding at 6 months would interfere with analysis of 12-month efficacy results. This should allay some concerns about data integrity."
    Dec 11 12:38 PM | Likes Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    When drugs have overlapping toxicities it is generally unwise to combine them, especially if grade 3/4.
    Nov 25 10:47 AM | 1 Like Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    The very high rates of Grade 3/4 thrombocytopenia, anemia and neutropenia are especially difficult on older patients(>65). They make up a large portion of treated pancreatic patients, so it's important to keep in mind the myelosuppressive nature of the Gem+TH-302 regimen.

    Folfirinox regimen
    http://bit.ly/WMvRod

    Nab-paclitaxel regimen
    http://bit.ly/UT6bA3
    Nov 25 02:38 AM | Likes Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    You seem to forget Merck KGaA is probably the worst big pharma you could be partnered with. There is a clear gap between their commercial and clinical teams. Abraxane+TH-302+/- Gemcitabine wont be tolerable; likely worse than FOLFIRINOX.

    "The improvement of MOS by Abraxene over Gemcitabine alone was 2 month."

    Flat out speculation on your part. We dont know this at all; based on design and size of trial, at a minimum it showed 1.5 months benefit in OS. KOLs who were a part of the trial, expected it to add 3-4 months.
    Nov 15 05:39 PM | Likes Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    You do realize that LifeSci Advisors is a paid by clients to put out research.

    Despite his assertion, talk to any oncologist and they will likely disagree with you. The QOL would be low on such a regimen.
    Nov 15 09:01 AM | Likes Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    TH-302 and Abraxane would not be very tolerable at all
    Nov 13 01:07 PM | Likes Like |Link to Comment
  • An Analysis Of Celgene's CVR For Abraxis [View article]
    Celgene announced positive data in pancreatic cancer for Abraxane + Gem combo. Data at ASCO GI.
    Nov 10 05:03 PM | 1 Like Like |Link to Comment
  • Teva: Rumors Of Copaxone's Demise Have Been Greatly Exaggerated [View article]
    - BG-12 and Lemtrada will certainly eat up a lot of Copaxone and interferon sales. Both drugs change the treatment paradigm and allow patients to live more functional lives. Over time, Copaxone sales will decline as physicians become more educated. Patients will also seek better options.

    - Laquinimod is not worthwhile.
    Nov 6 06:30 PM | Likes Like |Link to Comment
  • Multiple Catalysts Ahead For Depomed [View article]
    If you look at companies like spectrum and santarus, they have been able to take products like Gralise and grow them into the hundreds of millions in annual sales. Even $100 million in annual sales for Gralise, would value the company at about $300 million. I am sure you know that the average M&A multiple, in the past 5 years, has been between 3-5x annual sales.

    So, from a fundamental perspective, the company has room to go higher, in a 1-2 year timeframe. I think Serada is mostly a distraction and a wild card.

    Royalty revenues are a huge driver of revenue as well.

    I hope this helps you.
    Nov 4 12:29 AM | 1 Like Like |Link to Comment
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