Ann: Investor Presentation, page-30

In my opinion, they may have been blinded by the need for animal toxicity standards, otherwise may have raised at $2.00s

Regardless, the duration of animal toxicity studies for pharmaceuticals depends on the type and purpose of the study, as well as the regulatory requirements for the specific drug under development. Here are the general timelines for common types of toxicity studies:
1. Acute Toxicity Studies
Purpose: Assess the immediate toxic effects after a single or short-term dose.
Duration: Usually completed within 2-4 weeks, including observation and data analysis.
2. Subacute (Repeated Dose) Toxicity Studies
Purpose: Evaluate the effects of repeated dosing over a short period, typically 14 to 28 days.
Duration: Can take 1-2 months, including dosing and analysis.
3. Chronic Toxicity Studies
Purpose: Assess long-term toxic effects, usually to support chronic administration in humans.
Duration: Lasts 3, 6, or 12 months, depending on regulatory requirements.

As far as the FDA approval timeline for a 505(b)(2) pathway submission:
1. Pre-Submission (Pre-IND Meeting):Sponsors may request a pre-IND meeting with the FDA to clarify requirements. This phase typically takes 1-3 months to schedule and prepare.
2. Priority Review: 6 months after acceptance.

What Influences Timing?
- Whether the drug leverages existing safety/efficacy data.Complexity of modifications (e.g., dosage, formulation, or route of administration).
- FDA’s workload and feedback cycles.
- Whether the application qualifies for expedited programs like Fast Track or Breakthrough Therapy.

The 505(b)(2) pathway is faster than traditional NDAs because it allows reliance on existing data, reducing the need for full clinical trials. However, precise timelines depend heavily on the specific drug and regulatory interactions.

As far as launch, once they do partner with Big Pharma, if FDA approval granted in 2025, i believe new product launch planning, targeted clinical referral network groups, online platforms, key opinion leaders, etc - would all occur leading into FDA approval in order to realise sales and revenue in 2025.

In my opinion Q2 2026 for commercialisation and realisation of revenue is extremely conservative...

I would expect an update on expanding the product portfolio within the coming weeks /month given it was the first of the upcoming milestones referenced. I alsoi believe this cap raise will absorb some of the costs associated with expanding the product portfolio..

Only my opinions...