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  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    Good luck
    Sep 20 07:55 AM | Likes Like |Link to Comment
  • Northwest Biotherapeutics: U.K. May Grant Early Patient Access For DCVax-L Prior To Formal Approval [View article]
    Starting the phase 2 before finishing phase 1 was built into the protocol before the trial started. It was not a last minute decision. The primary goal of phase 1 is establishing safety and this has been done. While most people focus on efficacy of drugs, safety is as important. The amazing thing about dendritic cell cancer vaccines is that they are safe and dramatically so when compared to chemotherapy, targeted therapies or monoclonals. This is one of the reasons that PEI and MHRA have made the early access decisions.

    Safety is well established as was the expectation when the trial protocol was written. Remember that DCVax Direct is dealing with inoperable patients who are heading for hospice. With safety established, it is quite reasonable to see if the interesting signals of efficacy that we have seen in phase 1 and animal models can be replicated in a larger 24 patient phase 2 trial focused on one cancer. The FDA's action has some similarities to the PEI and MHRA early access decisions in that it is trying to speed the development process for a new drug addressing an unmet medical need.

    As for the secrecy of the CEO, you are incorrect. NWBO has tried to be transparent with releasing data on the phase 1 DCVax Direct. This triggered a series of attack articles from AF which have proven to be specious but continue to plague the stock. And amazingly, just two hours after AF publlished the highly misleading Buzdar blog, they were sued by a law firm for stock maniulation in which they cited AF's article as the reason. Isn't that an amazing coincidence?
    Sep 18 02:06 PM | 6 Likes Like |Link to Comment
  • Behind The Promotion Of Northwest Bio [View article]
    There is a distinct odor emanating from Retrophin.
    Sep 17 04:12 PM | 1 Like Like |Link to Comment
  • ImmunoCellular to proceed with ICT-107 Phase 3 despite failing Phase 2 [View news story]
    For a detailed discussion of this you might want to read an article on my website. The link is

    http://bit.ly/1s6IUBg
    Sep 17 12:15 PM | 1 Like Like |Link to Comment
  • Behind The Promotion Of Northwest Bio [View article]
    The manipulation of NWBO and many other companies by short sellers is blatantly obvious to investors. I think it is inevitable that the regulators and law enforcement agencies will be drawn into an investigation. In my opinion, this is one of the largest criminal enterprises in America.
    Sep 17 08:27 AM | 4 Likes Like |Link to Comment
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    In my opinion, the best hope for IMUC is that NWBO succeeds in the phase 3 trial. This would validate the dendritic cell technology and make it much easier for IMUC to fund the development of ICT-107 and other products in a broad number of tumors through partnering.
    Sep 17 08:24 AM | 1 Like Like |Link to Comment
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3 [View article]
    My estimate is from NCI. I have previously used the 12,000 number myself. It doesn't matter. An approval of ICT-107 would result in a huge move in the stock regardless of whether the number is 3500 or 12,000.
    Sep 17 08:20 AM | Likes Like |Link to Comment
  • 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 | 1 Like 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
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