If 11THREE and Univec fully intend to launch the RELIEFTA Transdermal Pain Patch as FDA approved prescription, it's a 2-3+ year journey, to put it simply, the RELIEFTA Patch is labeled with 5% Lidocaine--https://11threetech.com/ RELIEFTA website it's listed as just a multi-cannabinoid: https://reliefta.com/ easy just an OTC product sold now, no Labeler or NDC codes are needed.
David Dalton needs to be honest investors,
Without public records of human clinical trials and FDA filings, the product cannot legally be sold as a prescription patch or paid for by insurance. From the day formal human trials are first initiated to the day final FDA approval is granted, the realistic commercial timeframe spans 2 to 3+ years. Because there is no public record on ClinicalTrials.gov showing that Phase 1 (human trials) has even started, the timeline for an "Rx Only" launch has not yet begun.
A $5 million capital deck might cover the early-stage clinical trial setup and initial Phase 1/bioequivalence studies, but it is not enough money to fund human trials, pay federal regulatory fees, build cGMP manufacturing, keep the lights on for 30 months, and fund a commercial product rollout. This doesn't include the Pat Kelly or David Dalton pay!!!
There's no way there can be an FDA approved prescription patch, 2026-2027 maybe 2028.
Nobility isn't written in the words a man writes of himself on paper it is defined by the actions he takes: True character and nobility are proven through consistent, concrete actions...not promotional declarations or self-authored promises.
In business, empty claims eventually buckle under the weight of tangible evidence. A track record built on verified results will always carry more authority than any narrative written on paper.
A labeler code doesn't matter if products are never assigned to it by the FDA : https://www.fda.gov/search?s=Univec+Inc&i...=rel_DESC#
Disclaimer: Not advice to buy sell jus info from public records
PL
David Dalton needs to be honest investors,
Without public records of human clinical trials and FDA filings, the product cannot legally be sold as a prescription patch or paid for by insurance. From the day formal human trials are first initiated to the day final FDA approval is granted, the realistic commercial timeframe spans 2 to 3+ years. Because there is no public record on ClinicalTrials.gov showing that Phase 1 (human trials) has even started, the timeline for an "Rx Only" launch has not yet begun.
A $5 million capital deck might cover the early-stage clinical trial setup and initial Phase 1/bioequivalence studies, but it is not enough money to fund human trials, pay federal regulatory fees, build cGMP manufacturing, keep the lights on for 30 months, and fund a commercial product rollout. This doesn't include the Pat Kelly or David Dalton pay!!!
There's no way there can be an FDA approved prescription patch, 2026-2027 maybe 2028.
Nobility isn't written in the words a man writes of himself on paper it is defined by the actions he takes: True character and nobility are proven through consistent, concrete actions...not promotional declarations or self-authored promises.
In business, empty claims eventually buckle under the weight of tangible evidence. A track record built on verified results will always carry more authority than any narrative written on paper.
A labeler code doesn't matter if products are never assigned to it by the FDA : https://www.fda.gov/search?s=Univec+Inc&i...=rel_DESC#
Disclaimer: Not advice to buy sell jus info from public records
PL
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