Jay has said that we are not going to be the company to bring Leron to market. Maybe he's changed his mind, but I doubt it. Adding 3 or 4 employees does not make us able to compete with the giants. It's just what we need for the next steps.
Also want to say, I think for the last time, that we aren't going to "apply for accelerated approval" in Jan. 2027, as My69 seems to think. A lot of people on the Reddit board and a few on this one don't seem to be aware what a massive undertaking a BLA or NDA is, even with AI. A typical BLA is hundreds of thousands of pages -- sometimes over 500,000 pages. It includes exhaustive development reports, raw data, and case report forms. Unless we are still using Samsung to produce the drug, just the Chemistry/Manufacturing segment would require months and months of work. What Dr. Jay meant was asking the FDA if we should BEGIN the process of accelerated approval. We are not GETTING accelerated approval at a single meeting. Once we've compiled a BLA, accelerated approval makes the process go much faster.
I'm letting AI tell us what the five modules of a BLA are:
Module 1: Administrative Information and Regional Requirements
Form FDA 356h (Application to Market a New Drug, Biologic, or Antibiotic for Human Use)
Application index and cover letters
Proposed prescribing information (labeling) and container/package details
Patent and financial disclosure information
Module 2: Summaries
High-level overviews and summaries of quality, nonclinical, and clinical data (typically 50–200 pages)
Quality Overall Summary, Nonclinical Overview, and Clinical Overview\
Module 3: Quality / Chemistry, Manufacturing, and Controls
Detailed information on product characterization, purity, and potency
Manufacturing process, cell lines, purification steps, and lot release testing
Reference standards and establishment/facility floor diagrams
Module 4: Nonclinical Study Reports
Pharmacology, pharmacokinetics, and toxicology study reports
Animal testing data demonstrating safety before human exposure
Module 5: Clinical Study Reports
Human pharmacokinetics and bioavailability data
Phase 1, Phase 2, and Phase 3 clinical trial reports, safety and efficacy data, statistical analysis, and individual patient Case Report Forms
Also want to say, I think for the last time, that we aren't going to "apply for accelerated approval" in Jan. 2027, as My69 seems to think. A lot of people on the Reddit board and a few on this one don't seem to be aware what a massive undertaking a BLA or NDA is, even with AI. A typical BLA is hundreds of thousands of pages -- sometimes over 500,000 pages. It includes exhaustive development reports, raw data, and case report forms. Unless we are still using Samsung to produce the drug, just the Chemistry/Manufacturing segment would require months and months of work. What Dr. Jay meant was asking the FDA if we should BEGIN the process of accelerated approval. We are not GETTING accelerated approval at a single meeting. Once we've compiled a BLA, accelerated approval makes the process go much faster.
I'm letting AI tell us what the five modules of a BLA are:
Module 1: Administrative Information and Regional Requirements
Form FDA 356h (Application to Market a New Drug, Biologic, or Antibiotic for Human Use)
Application index and cover letters
Proposed prescribing information (labeling) and container/package details
Patent and financial disclosure information
Module 2: Summaries
High-level overviews and summaries of quality, nonclinical, and clinical data (typically 50–200 pages)
Quality Overall Summary, Nonclinical Overview, and Clinical Overview\
Module 3: Quality / Chemistry, Manufacturing, and Controls
Detailed information on product characterization, purity, and potency
Manufacturing process, cell lines, purification steps, and lot release testing
Reference standards and establishment/facility floor diagrams
Module 4: Nonclinical Study Reports
Pharmacology, pharmacokinetics, and toxicology study reports
Animal testing data demonstrating safety before human exposure
Module 5: Clinical Study Reports
Human pharmacokinetics and bioavailability data
Phase 1, Phase 2, and Phase 3 clinical trial reports, safety and efficacy data, statistical analysis, and individual patient Case Report Forms
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