Seeking Alpha

Smith On Stocks

 
View as an RSS Feed
View Smith On Stocks' Comments BY TICKER:
Latest  |  Highest rated
  • Antares: An Analysis Of FDA Briefing Documents For September 17th Advisory Committee Meeting On Testosterone Replacement Products [View article]
    The diversity of the pipeline and the lack of transparancy on the licensed drugs owing to the licensees desire to not let competitors know the status of the licensed products suggests to me, as to you, that they are probably not valued properly at present. The 505 (b) 2 pathway offers a deep pipeline with products that can be brought to market rapidly. This is a unique company.
    Sep 12 03:26 PM | Likes Like |Link to Comment
  • Cytokinetics: Will The FDA Agree To A New Phase 3 Trial For Tirasemtiv? [View article]
    I can't answer your question and ultimately only the FDA can. The KOLs that CYTK is relying on believe that SVC is a suitable primary endpoint. Whether that is reflective of the broad AOL provider community, I don't know. If you are referring to the MI data on omecamtic in ATOMIC please check this link. http://bit.ly/1wfp30T

    Thanks for the comment.
    Sep 9 06:19 PM | Likes Like |Link to Comment
  • Antares: An Analysis Of FDA Briefing Documents For September 17th Advisory Committee Meeting On Testosterone Replacement Products [View article]
    Thank you for your comments. They add great value to the discussion. I have a lot of issues with Seeking Alpha, but the platform they provide for group participation allows a mediocre article like mine to become a great one because of comments from serious investors like you. I learn much from comments to my articles.
    Sep 9 06:13 PM | 1 Like Like |Link to Comment
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    As Yogi Berra so aptly phrased it, projections are very hard, especially about the future.
    Sep 9 06:09 PM | 1 Like Like |Link to Comment
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    I think that IMUC will have a difficult time establishing a manufacturing facility in the UK. Dealing with living cells is much more complex than just making a small organic molecule. It took NWBO over two years to transfer their technology to Europe. I suspect that any phase 3 trial will be conducted in the US.
    Sep 9 06:07 PM | Likes Like |Link to Comment
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    Succinct summary of my view.
    Sep 9 06:05 PM | Likes Like |Link to Comment
  • Behind The Promotion Of Northwest Bio [View article]
    I will be there. Check my latest article on NWBO. http://bit.ly/1weeQll
    Sep 8 02:06 PM | 3 Likes Like |Link to Comment
  • The Case Of Northwest Biotherapeutics' Missing DMC Recommendation [View article]
    You are correct. There have been no lawsuits filed. There have only been notices of investigations. This indicates the law firms can't find enough potential clients to make law suits an attractive economic undertaking.I have corrected this language in my website. Here is the link to my article. http://bit.ly/1weeQll
    Sep 8 02:04 PM | 3 Likes Like |Link to Comment
  • Antares: An Analysis Of FDA Briefing Documents For September 17th Advisory Committee Meeting On Testosterone Replacement Products [View article]
    I share your optimism on the stock.
    Sep 4 01:21 PM | 2 Likes Like |Link to Comment
  • Antares: An Analysis Of FDA Briefing Documents For September 17th Advisory Committee Meeting On Testosterone Replacement Products [View article]
    I stated in this report " the FDA now seems to be saying that this (cardiovscular risk) is not a concern based on recent studies. However, the FDA may still ask manufacturers to perform a long term study to resolve this."
    Sep 4 01:03 PM | 1 Like Like |Link to Comment
  • Cytokinetics: Will The FDA Agree To A New Phase 3 Trial For Tirasemtiv? [View article]
    Thanks for pointing this out. I was so tied up with the attack article launched against me at that time that I missed it. The key from CYTK's standpoint is how well and aggrssively the product is marketed.
    Sep 4 08:16 AM | 1 Like Like |Link to Comment
  • The Case Of Northwest Biotherapeutics' Missing DMC Recommendation [View article]
    I believe that if my memory serves me that the six patients treated using the lysate dendritic cell loading approach all had Gliadel wafers indicating that they were recurrent GBM patients, not newly diagnosed. The former CEO of IMUC, Manesh Singh, used to put this slide in his presentation and was called out on it. I don't think they use it any more.
    Sep 3 10:23 PM | 2 Likes Like |Link to Comment
  • Cytokinetics: Will The FDA Agree To A New Phase 3 Trial For Tirasemtiv? [View article]
    I don't think any company would partner for tirasemtiv at this point. However, if CYTK got an SPA for a phase 3 trial using SVC as the primary endpoint, I think the chances of finding a partner might be very good. As I said in this report, if the FDA does not agree to SVC as the primary endpoint, the drug will be abandoned.

    There has been talk of Amgen licensing omecamtiv in Europe. I don't know how real it is. As to whether this would be good or bad, it all depends on who the licensor would be. Amgen has been more focused on oncology and endocrinology. It would have to build expertise in cardiology and primary care which is the physician target for omecamtiv. A licensing deal could be good for CYTK if it brings more marketing clout. However, Amgen probably will want to see how COSMIC and the phase 3 turns out before partnering
    Sep 3 10:23 PM | Likes Like |Link to Comment
  • ImmunoCellular Plans To Move ICT-107 Forward Into Phase III Trials Based On New Sub-Group Analysis Presented At ASCO [View article]
    The issue with an ICT-107 phase 3 trial is that the trial would probably start in mid-2015 and finish in mid-2018. This is a long time to wait. The company will have about $10 to $15 million of cash in mid-2015. I think that funding the trial and funding other operations of the company will take about $90 to $100 million. IMUC will need to raise about $90 to $100 million in capital by the end of 2018. This is a formidable challenge for a Company with a market capitalization of only $70 million. This link will give you a more detailed analysis of IMUC. http://bit.ly/1t1Vaih
    Sep 3 10:23 PM | 1 Like Like |Link to Comment
  • Cytokinetics: Will The FDA Agree To A New Phase 3 Trial For Tirasemtiv? [View article]
    Check this link http://bit.ly/1u265v2
    Sep 3 10:23 PM | Likes Like |Link to Comment
COMMENTS STATS
894 Comments
1,422 Likes