That's my thinking. Didn't IPIX PR they were appro
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Posted On: 07/13/2020 1:32:05 PM
That's my thinking. Didn't IPIX PR they were approaching FDA already?
"The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
https://www.fda.gov/drugs/types-applications/...pplication
I'm thinking a pre meeting has happened.There may be another one just prior to IND submission With the GMU dosage/toxicity data in hand or soon to be, IPIX can file an IND this quarter. In the meantime negotiations with a CRO can be firmed up. Going with a CRO will preclude having to enlist a CMO until IPIX finds one that can improve the company going forward..A month or so for CRO to pull together a site,nurse, analysts and test subjects would put clinical kick off in October ish.
Looking for a capital raise post positive P2 data.
"The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
https://www.fda.gov/drugs/types-applications/...pplication
I'm thinking a pre meeting has happened.There may be another one just prior to IND submission With the GMU dosage/toxicity data in hand or soon to be, IPIX can file an IND this quarter. In the meantime negotiations with a CRO can be firmed up. Going with a CRO will preclude having to enlist a CMO until IPIX finds one that can improve the company going forward..A month or so for CRO to pull together a site,nurse, analysts and test subjects would put clinical kick off in October ish.
Looking for a capital raise post positive P2 data.
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