Seeking Alpha

14195192

14195192
Send Message
View as an RSS Feed
View 14195192's Comments BY TICKER:
Latest  |  Highest rated
  • Threshold Pharmaceuticals: Hard Road Toward Success [View article]
    Thanks for making the change. It happens all the time and the company actually has made efforts to strengthen use of its name. I can't tell you how many times I have seen it in Bloomberg, WSJ, Barron's and other financial press as Merck and Co.
    Jul 29, 2015. 07:02 AM | Likes Like |Link to Comment
  • Threshold Pharmaceuticals: Hard Road Toward Success [View article]
    They are not partnered with Merck and Co but Merck KGaA which is known a s Merck Serono outside of US and EMD Serono inside US. You need to make an edit to your article as you are using the wrong partner company.

    Nice DD. The question is not if the drug will work if it reaches the hypoxia areas of tumors(seen in preclinical models) but can the drug be delivered to these areas. I give it a coin flip.
    Jul 28, 2015. 07:11 AM | Likes Like |Link to Comment
  • The Most Important Question For Celgene Investors After The Receptos Acquisition [View article]
    Why is everyone thinking that Ozanimod is going to be a huge winner with MD's who treat MS. 2 weeks ago Genetech/Roche announced that their drug Ocralizumab beat Rebif in relapse rate reduction and disability. This is the first time another medication beat a platform MS therapy in disability in both p3 trials. We haven't seen the numbers (to be presented at ECTRIMS in October 2015) but If they were anything like the p2 look out 90%reduction in relapse and MRI.

    Here are reasons I believe this acquisition was a huge mistake in MS:
    1. The drug will work and be approved however will oral medications in MS be viable? Why take a pill every day when you can take an infusion once every 6 months?
    2. All of the newer drugs will have immunosuppresive qualities with its predecessor fingolimod(Gilenya) having 2 treatment naive and over 11 pre treated Natilizimab(tysabri) patients develop PML. Where is the risk benefit when Ocralizumab has demonstrated superior dats vs active comparitor.
    3. Patients will still have to be monitored for cardiac risk factors even thought they will be reduced with this new drug
    4. Gilenya will be generic by then.
    5. Compliance is a non factor with an infusion and patients skip doses all the time
    6. Physicians all have infusion suites which they like to fill with patients to make money.
    7. Never underestimate Biogen as they are the experts in marketing and new entrants have struggled without MS relationships (Novartis and Genzyme)

    Merck Serono returned their S1P drug for many of these reasons as they were also Behind.

    I have no opinion on Celgenes future but wanted to get this out there as it has been overlooked in my opinion.
    Jul 21, 2015. 07:11 AM | 1 Like Like |Link to Comment
  • Celgene: New Deals Creating More Compelling Investment Case [View article]
    Why is everyone thinking that Ozanimod is going to be a huge winner with MD's who treat MS. 2 weeks ago Genetech/Roche announced that their drug Ocralizumab beat Rebif in relapse rate reduction and disability. This is the first time another medication beat a platform MS therapy in disability in both p3 trials. We haven't seen the numbers (to be presented at ECTRIMS in October 2015) but If they were anything like the p2 look out 90%reduction in relapse and MRI.

    Here are reasons I believe this acquisition was a huge mistake in MS:
    1. The drug will work and be approved however will oral medications in MS be viable? Why take a pill every day when you can take an infusion once every 6 months?
    2. All of the newer drugs will have immunosuppresive qualities with its predecessor fingolimod(Gilenya) having 2 treatment naive and over 11 pre treated Natilizimab(tysabri) patients develop PML. Where is the risk benefit when Ocralizumab has demonstrated superior dats vs active comparitor.
    3. Patients will still have to be monitored for cardiac risk factors even thought they will be reduced with this new drug
    4. Gilenya will be generic by then.
    5. Compliance is a non factor with an infusion and patients skip doses all the time
    6. Physicians all have infusion suites which they like to fill with patients to make money.

    Merck Serono returned their S1P drug for many of these reasons as they were also Behind.

    I have no opinion on Celgenes future but wanted to get this out there as it has been overlooked in my opinion.
    Jul 18, 2015. 08:24 PM | 3 Likes Like |Link to Comment
  • An Expert's Opinion On Neuralstem's Phase 2 Results [View article]
    A period to establish what the patients decline is before treatment. Then treatment and see if treatment accelerated, maintained or slowed down progression.

    This ensures a way to determine what your patients in trial baseline decline is and see if there is a treatment effect on decline as has been suggested by AF and others.
    Mar 20, 2015. 01:19 PM | 4 Likes Like |Link to Comment
  • 15 Biotech Names For 2015 [View article]
    http://bit.ly/1KDHzZk

    New tnxp if presentation: slide 15 shows pbo had 19.61 responders >30 pct response vs 33.01 on 2.8mg SL on tonix product.

    Would love to hear your thoughts Jason now that the data is public. It came in above what you stated above.

    Thanks
    Jan 12, 2015. 06:58 PM | 1 Like Like |Link to Comment
  • Highlights From NQ Mobile's 20-F [View article]
    http://bit.ly/1tBBFQT

    They also didn't have any issues with NQ comments about them in the 20-F

    If they were such a fraud and PWC knew it why not blow the whistle.

    While I am at it why not also discuss that it is not the same PWC in us but a franchise in china using the same name.

    NQ may have issues but enough with the fraud. Focus your attention on business model flaws and your arguments would sound more intelligent and also be more useful for all
    Oct 28, 2014. 09:23 AM | 2 Likes Like |Link to Comment
  • Highlights From NQ Mobile's 20-F [View article]
    http://bit.ly/1nMt64Z

    While no investor is ever happy about dilution one also needs to understand what was acquired and the effect it will have bottomed line.

    Time will tell but Nation sky and FL mobile were very good use of shares and we shall see what these offer.

    In fairness you probably didn't see this before printing your article but should address it rather than blindly bash
    Oct 28, 2014. 07:39 AM | 12 Likes Like |Link to Comment
  • Takeaways From WidePoint's Recent Stock Offering Announcement [View article]
    Looks like they priced at $1.45.

    Justin what is your revised model look like now after this offering.
    Oct 23, 2014. 08:03 AM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I was thinking same example when I wrote the above which was a reply to a comment which has no been deleted.

    I would highly advise everyone to review ACAD. Very similar paths I hope
    Oct 2, 2014. 10:37 AM | Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    While I agree with you that nothing can be predicted you are just discounting that this drug worked on 14 out of 16 endpoints? Some of these used for FDA approval for other FM drugs.

    This is not a sub group analysis as many companies like to do and say we are moving forward because we feel it will work in this group. I agree that is a huge red flag.

    Look at it this way: you are now making a new investment decision based on this data set amongst all the other data sets. Would you make a investment based on these facts? Perhaps waiting 72 days for the FDA meeting might be a prudent decision if you are conservative

    Joe Simply presents a thesis and it's up to everyone to make their own decisions. There are numerous MD's and other smart people who agree with him.

    I for one would never blindly just follow. Did my own research and still believe not because I want to chase but because I feel this really was good data and helps me to make a better decision when I buy back in

    Good luck
    Oct 2, 2014. 07:05 AM | 2 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    The study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12 (p=0.086 by mixed-effect model repeated measure analysis, p=0.172 by jump-to-control, multiple imputation analysis).

    To clarify Dr Eisemans point when you take out those who had didn't drop out you get the .086 vs when you include them you get .172 which means those who drop out get no improvement scores. It doesn't mean they didn't improve but you assume not because they discontinued

    The latter is a much more conservative approach but if you could hit it would be very impressive. Hope this helps
    Oct 2, 2014. 06:52 AM | 1 Like Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I sold Monday on the flash rise that was halted around 7.25 which was a $4 share loss and looking to renter in a few days around 6 or even high 5. Uncertainty will cause this to bleed and if I can buy more shares with same money it will lower my cost average and thus break even point. I may trade it as we have 73 days roughly to hear something and with a known timeframe there is little risk to missing the "big" pop. Like many other I may even add to my original holdings as well. I am looking long term.

    I believe this drug has demonstrated significant biological activity and will ultimately get approved. As I have already said with a different end point choice of percent of patients with 30% improvement we would have all been thanking joe et al for all their hard work with huge smiles on our faces. Like joe has stated the FDA will hopefully agree with us and guide to what is needed and the best case is only 1 more phase 3 trial with approval based upon agreed upon endpoint.

    My experience is 15 years as a biotech rep in numerous specilaties. What I offer is the ability to discuss with mds openly and honestly if they would use this type of product and I have been convinced that there is a need and it would be used. Best of luck
    Oct 1, 2014. 05:19 PM | 3 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    I used to work for a company that missed its primary but was given a SPA special protocol assessment that if they meet the 2nd trial with statistical significance they would approve the drug.

    The first trial used an non traditional endpoint mean change in Vo2 vs the stAndard 6 minute walk test. The trial missed but hit the 6MW. This was in pulmonary arterial hypertension.

    The 2nd trial used the more standard endpoint as it's primary.

    My point is the could meet FDA and say if we run another trial with either sleep or percent of patients with a 30pct improvement and you hit we will approve.

    The SPA acts as a road map to approval.
    Oct 1, 2014. 02:15 PM | 4 Likes Like |Link to Comment
  • Tonix Is A Buy On Endpoint Circumstances [View article]
    The glass is half full!
    Sep 30, 2014. 02:32 PM | Likes Like |Link to Comment
COMMENTS STATS
85 Comments
154 Likes