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Vertex Pharmaceuticals Incorporated Message Board

justrpaul 10 posts  |  Last Activity: Dec 2, 2014 5:55 PM Member since: Jan 16, 2004
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  • Reply to

    What comes first?

    by fpmiike Dec 2, 2014 11:28 AM
    justrpaul justrpaul Dec 2, 2014 5:55 PM Flag

    Paperwork for the reverse stock split was filed on 11/25/14. Also, 8'k filing today showing 5% ownership of Incuron was transferred to the jv partner, giving the partner majority control. {CBLI still has 46%.}

  • justrpaul justrpaul Nov 28, 2014 1:03 PM Flag

    If their waffles were radioactive, it might be relevant to this board.

  • Reply to

    Aeolus slide show presentation update

    by holeinmypocket1967 Nov 24, 2014 10:56 AM
    justrpaul justrpaul Nov 26, 2014 1:21 PM Flag

    Since you have never heard of this kind of study, I should remind you that I posted the following back in September.

    Has AOLS proposed and the FDA confirmed a specific human dose for the ARS indication?

    Sep 26, 2014 1:37 PM by justrpaul

  • The press release for the pancreatic cancer results for 137 noted they could move towards a Phase II study, based on earlier work with 137. It would certainly be in the normal course of biopharma deals for a major company to partner with CBLI on a Phase 2 study and provide some cash in the bargain. Might not be enough to solve all of their funding needs, but it could help and add to the credibility of the company.

  • Reply to

    animal rule

    by bbranch50 Nov 15, 2014 12:18 PM
    justrpaul justrpaul Nov 17, 2014 11:10 AM Flag

    Becoming an 'expert by google' is a very dubious proposition. Nevertheless, you still do not understand the 'animal rule'. You need to think of Dr. Mengele to see what unethical is. In the case of the FDA, unethical refers to making people ill with radiation or snake venom, or whatever to then be able to test your drug on them. That would be unethical, so you test for efficacy on animals. None of that means that the FDA doesn't want human safety information for your drug. In fact, you can easily google and find that the do want that. Think of it this way, if it were unethical to test your drug on healthy human volunteers then why would the FDA ever approve it for use?

  • Reply to

    Holy cow!

    by holeinmypocket1967 Nov 12, 2014 4:07 PM
    justrpaul justrpaul Nov 15, 2014 12:02 PM Flag

    The Emergency Use Authorization (EUA) also requires safety data. The ALS work required dosing for a week, the ARS indication requires 60 days of dosing. What safety data will the FDA require when 60 days of continuous dosing are required? I've come to my conclusion. You may come to yours.

  • Reply to

    Holy cow!

    by holeinmypocket1967 Nov 12, 2014 4:07 PM
    justrpaul justrpaul Nov 14, 2014 7:06 PM Flag

    If as you say, health human safety studies are not required, why would Aeolus put this in their September SEC disclosure:

    Item 7.01. Regulation FD Disclosure
    On September 22, 2014, Aeolus Pharmaceuticals, Inc. (the “Company”) received notice from the U.S. Food & Drug Administration (“FDA”) that the clinical safety study in healthy normal volunteers proposed in its Investigational New Drug Application (“IND”) for AEOL 10150 in the pulmonary effects of Acute Radiation Syndrome (“Lung-ARS”) has been placed on clinical hold. The Company will work with its development partner, the Biomedical Advanced Research and Development Authority (“BARDA”), to respond to the FDA notice and provide any additional information requested. This notice will delay BARDA funding for the clinical study and its initiation until the FDA has reviewed the Company’s response and removed the clinical hold.

  • Reply to

    Holy cow!

    by holeinmypocket1967 Nov 12, 2014 4:07 PM
    justrpaul justrpaul Nov 14, 2014 3:58 PM Flag

    There is nothing in your quote from the FDA that counters my points, rather it supports them. It simply says you use the animal rule when you can't reasonably find candidate patients in the field.

  • Reply to

    Holy cow!

    by holeinmypocket1967 Nov 12, 2014 4:07 PM
    justrpaul justrpaul Nov 14, 2014 3:23 PM Flag

    You clearly don't understand what you are talking about and when challenged with a logical fact-based argument, resort to distortions and name calling. The animal rule does not at all say that it would be unethical to test in healthy humans. That is actually required. What would be unethical would be to subject humans to radiation and then try to cure them. Thus you have the use of animals to test efficacy, and then the testing of the required dosing found during the animal testing on healthy humans.

    As you are well aware the FDA has prevented AOLS from testing the drug on healthy humans. Whether AOLS will be able to ever test the required dosing on healthy humans is an open question. I highly doubt it.

  • Reply to

    Holy cow!

    by holeinmypocket1967 Nov 12, 2014 4:07 PM
    justrpaul justrpaul Nov 14, 2014 10:25 AM Flag

    If you are investing in a company seeking approval through the animal rule, it is important to understand what the animal rule is. Simply, it requires testing on animals to prove efficacy, and on humans to prove safety. The enormous stumbling block now for approval of 10150 is to find a path where the FDA will allow it to be tested on humans to prove safety, when the compound is known/suspected of causing genetic damage. Perhaps an insurmountable stumbling block.

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