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R. Saito  

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  • Will Generex Biotech Be Next to Join the Winner's Circle? [View article]
    Thanks for sharing your DD Michael.
    Jan 21, 2010. 09:15 AM | 2 Likes Like |Link to Comment
  • Upcoming events will move Javelin Pharmaceuticals (JAV) [View instapost]
    Sorry for the late reply to your comment. As you know, the news of a major strategic transaction came December 18th. My sources were right this time, although the merger has been quite complicated.
    Jan 20, 2010. 04:46 PM | Likes Like |Link to Comment
  • Santarus' Zegrid Facing Back-to-Back FDA Approval Dates [View article]
    Congratulations to all who followed this one.
    On the question about time between approval and launch, nobody really knows, but the size of the company is important. SP should be able to roll it out very quickly, especially since they had very good reasons to expect an approval this time around.
    As for the next FDA date, it is of lesser importance to the stock price. An added form of the drug may aid in some sales, but will also detract some from powder and capsules.
    Dec 1, 2009. 06:17 PM | Likes Like |Link to Comment
  • Readers Ask: MHTX, SPNG.OB, NRIFF.PK [View article]
    I believe SPNG is the victim of a smear campaign and their former accounting firm couldn't have picked a worse time to lose their accreditation. I see the products everywhere, we know this is a real company, now it's time for the company to prove this to us by finishing their audit. Lawsuits and problems will disappear when they do. My average is only $0.04 so I'm sitting pretty good, although I have more than a few martinis in it. A good 10K buys me a lifetime of martinis. I wish all SPNG holders good luck.
    Oct 21, 2009. 07:33 PM | Likes Like |Link to Comment
  • Spectrum Pharmaceuticals: Update [View instapost]
    Fusilev is sold only in 50mg vials at a price around $170-190 per vial, so with your conservative market penetration we're talking $150-200M in Fusilev sales. I personally believe it will be higher as docs will want to avoid the inactive isomer due to toxicity and the price difference is small. Here is one example from the web stating price, hope the link works:
    www.familymeds.com/onl...
    Oct 2, 2009. 08:12 AM | Likes Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    What can I say. The FDA has once again gone completely against their own guidance in their recommendations against both Clolar and Onrigin. Their guidance clearly states that AML treatments can be approved based on single-arm studies, and now they have decided against this. Earlier this year, ADLS was held to a new standard also; the FDA went against its guidance and ruled according to a new guidance that was just released in draft form for review. Well, I have to take one on the chin here, my call was wrong.
    Sep 1, 2009. 05:03 PM | Likes Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    Well, from here we have two important events, the ODAC meeting tomorrow and the actual FDA PDUFA decision date on December 12th. Additionally, news of a partnership would not come unexpected anytime around these two events. If the committe recommends Onrigin, we should have some explosive trading on our hands Wednesday. If the committee votes against Onrigin, my best advice is to hold until closer to the PDUFA date as these events tend to dip a stock far down on the first few days following the event, the price should recover again toward the PDUFA date in December in this case. A good example of this behavior is ADLS.OB this summer.
    Aug 31, 2009. 05:21 PM | Likes Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    I can only speak for myself when I say yes. Trading a stock like this takes nerves of steel. The gains on a positive advisory committee outcome could be tremendous. Always leverage your risk and never play a biotech stock with more than you are comfortable with, we should all follow this to be able to sleep at night.
    Aug 28, 2009. 02:30 PM | 1 Like Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    FDA's briefing documents are usually ugly. The briefing for Onrigin does not have anything unexpected, it's a very statistical analysis. Of particular note, the FDA does not question the patient selection. When the committee convenes, they will compare these results to the baseline, which is very poor and fairly well established for these patients. Vion seems to be well prepared to discuss confounders as it was expected the FDA would bring up these points. My sentiments remain unaltered, ODAC should recommend Onrigin for approval on Tuesday. As for the selloff this morning, it is not uncommon for shareholders to be scared of the FDA's briefing documents. Remember that it is the oncologists who will decide the fate of Onrigin, not the statisticians.
    Aug 28, 2009. 12:53 PM | 2 Likes Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    Bertrt, this is not the venue to compare chemistries, they are obviously different drugs. By similar I mean they both operate by antineoplastic activity, and there's no need for such words on this blog (antineaplastic that is). As for toxicity, I suspect Clolar is dosed over five days rather than a single infusion due to a higher toxicity, but I have not studied the dose ranging studies for Clolar.
    Aug 27, 2009. 05:06 PM | 1 Like Like |Link to Comment
  • Vion Pharmaceuticals' Onrigin: Good Chance of FDA Approval [View article]
    Adam Feuerstein is entitled to his opinions, sometimes he's right, sometimes he's wrong. Genzyme's Clolar is very similar to Onrigin in checmistry and toxicity, Onrigin wins the toxicity and can be admininstered in one large dose, while Clolar's toxicity is such that it takes five days of infusion for a single treatment. The market will be moving toward these two in the future. Clolar is a big drug for Genzyme, they have stated a $600M near term target for Clolar. As for Vion's management buying in, I can't answer that, but I am sure they are well loaded up on stock options.
    Aug 26, 2009. 10:54 AM | 3 Likes Like |Link to Comment
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