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meltdownman1 7 posts  |  Last Activity: 2 hours 54 minutes ago Member since: Aug 12, 1998
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  • meltdownman1 meltdownman1 2 hours 54 minutes ago Flag

    Replicant AVImoron!

    Sentiment: Strong Buy

  • My only concern on the treatment of patients with brain cancer is the makeup of the population of cancer patients. If I recall correctly these are patients who have nothing left to lose meaning that it may even be too late for Aldo. I would think that this would distort the data don't you think which in turn would be a negative? In addition, if a patient is that far along with brain cancer, the bodies uptake may be limited than say someone with much earlier stages of brain cancer don't you think? I am not a biologist but just questioning whether or not the docs at CYTR need to be promoting Aldo more to patients with earlier stages of brain cancer than the current population. However, the fact that this technology is being applied to a lot more forms of cancer is encouraging. I would be interested to see if it could ever be used for prostate and breast cancer. I don't know if Dox is even applicable to those forms of cancer but the link technology might be able to be applied to the meds used to treat those forms of cancer. Any ideas why it is not be used for breast and prostate cancers?

    Sentiment: Strong Buy

  • Incredible

    This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2

  • meltdownman1 meltdownman1 Sep 26, 2014 4:04 PM Flag

    NOT FDA APPROVED for ORPHAN INDICATION - CYTR can go ahead to develop Aldo with 7 year exclusivity for a disease that has been designated as Orphan Indication (generally rare disease affecting

    Sentiment: Strong Buy

  • Reply to

    Orphan Indication

    by meltdownman1 Sep 26, 2014 3:40 PM
    meltdownman1 meltdownman1 Sep 26, 2014 3:56 PM Flag

    Implemented in 1983, the basic intent of the US Orphan Drug Act (ODA) was to stimulate research, development, and approval of products that treat rare diseases. "In the US, these diseases are defined as those which affect less than 2,00,000 patients or those for which cost of development is unlikely to be covered through commercialisation. 'Orphan drugs' are thus used for rare diseases for which there is an unmet medical need," says Dr Chandrashekhar Potkar, Director-Medical and Regulatory Affairs, Pfizer. Examples of these diseases include severe combined immunodeficiency syndrome, cystic fibrosis, hairy cell leukaemia etc. Malaria and tuberculosis also are orphan indications in the US. The concept of orphan drug in the US, apart from covering pharmaceutical or biological products, also covers medical devices and dietary or diet products.

    "There is limited commercial opportunity for such drugs. However, research based pharma companies are able to apply their R&D expertise in partnership with government and other medical institutes for orphan indications with unmet medical needs," Potkar adds. Government provides incentives for sponsors undertaking research on orphan indications. These incentives can take form of tax credits for clinical research expenditure, grants in aid for clinical research, design assistance for investigating orphan indications (eg. open protocols for enrolling patients) and seven year market exclusivity. But the definition of orphan drugs and diseases and the incentives attached to them may vary in different countries depending on the prevalence of diseases there and the respective population strengths.

  • meltdownman1 by meltdownman1 Sep 26, 2014 3:40 PM Flag

    If a product with an Active Pharmaceutical Ingredient (API) is already approved for a rare disease indication, but a different formulation is believed to have a greater efficacy for the same rare disease indication, can an orphan designation be requested?

    The public policy objective of the Orphan Drug Act is to further the testing and marketing of products for rare diseases in which no current therapy exists or where the product will significantly improve the existing therapy.
    If a product has received marketing approval in the United States for use in the proposed orphan indication, the only way the proposed product can be designated as an orphan drug is if the sponsor provides a reasonable hypothesis that their product is “clinically superior” to the approved product by means of greater effectiveness, greater safety, or that it provides a major contribution to patient care (MC–to-PC).
    Further, if orphan drug designation is ultimately granted, in order for the product to receive orphan drug exclusive approval for this indication, the sponsor must actually demonstrate the superiority claim by showing their product is significantly more effective than the approved product in a clinical trial, is safer in a substantial portion of the target population, or can provide a major contribution to patient care.
    Any claim for clinical superiority could require a head-to–head trial.

    Sentiment: Strong Buy

  • meltdownman1 by meltdownman1 Sep 24, 2014 8:51 PM Flag

    I am now convinced that you would rather see these patients die rather than have this medicine succeed. You are really one sick fucccer. This obsession you have with wishing people would die so you can prove a point is beyond rational and you really need to seek some professional help.

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