ILA.ax

[HAWKDOG]

Speculative pharma play. Owned about 6 months now.
Tightly held.  Mgmt sold last company for a mit full.

webinar that outlines the guts of the company -
https://youtu.be/RiRjEOwtKLQ?feature=shared

19 September 2025

ASX Announcement
US Food & Drug Administration meeting request
granted
• FDA grants Island a Type C meeting under Galidesivir's open Investigational
New Drug (IND) application
• Provides ILA with the opportunity to seek alignment on utilising Animal Rule to
fast-track Galidesivir approval for use in Marburg
• Additional feedback to provide clarity on pending animal study design and
Priority Review voucher eligibility
• Written responses from the FDA expected by 12 November 2025 (US time)
• Island to submit comprehensive briefing package with relevant historical data
to regulator in the coming weeks
MELBOURNE Australia, 19 September 2025: Australian antiviral drug development
company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to
advise that the US Food & Drug Administration (FDA) has granted the Company's Type
C meeting request as part of Galidesivir's open Investigational New Drug (IND)
application (refer ASX announcement: 1 September 2025).
This meeting provides the Company with the opportunity to seek alignment with the
regulator on the use of the FDA's Animal Rule for Galidesivir's development and
approval. Island will also request guidance on its proposed clinical study design, and
Galidesivir's eligibility for a Priority Review Voucher (PRV).
The FDA has determined that written feedback will be the most appropriate means for
responding to this meeting request and has indicated that it intends to provide this to
the Company by 12 November 2025 (US time). Prior to receipt of responses, Island will
submit a full briefing package, which includes all relevant historical Galidesivir data.
Concurrently, Island is continuing to advance negotiations with strategic
counterparties to progress an animal study using Galidesivir in Marburg. This study
remains on track to commence and complete in the next quarter.
Management commentary:
CEO and Managing Director, Dr David Foster said: "Securing this Type C meeting
with the FDA represents an important milestone in advancing Galidesivir towards
approval. The guidance from the regulator is expected to provide clarity on the
potential to leverage the Animal Rule, as well as important insight into study design
requirements and Galidesivir's eligibility for a PRV. This meeting will be supported by
a comprehensive briefing document, scheduled to be sent to the regulator in the
coming weeks."
"We look forward to receiving feedback in the coming months, as we continue to
advance additional opportunities to underpin our stated strategy of becoming a
trusted provider to government stockpiles, by supplying solutions for high-priority
public health threats like Marburg."

[HAWKDOG]

ILA over 50 cents today - acting like a gold stock - now the guessing game on when to sell starts.

[HAWKDOG]

Halted
Webinar Monday to discuss meeting with FDA

[HAWKDOG]

Webinar today at 12:30 to explain FDA response - news has to be coming in the next hour or two.
Coming off of its halt today at some point as well.

[HAWKDOG]

news out.  Ann: FDA agrees Animal Rule pathway and PRV eligibility

[HAWKDOG]

FDA agrees Animal Rule pathway and Priority Review
Voucher eligibility for Galidesivir in Marburg

Responses significantly de-risk Galidesivir regulatory pathway – Island is now the
first Australian company with an opportunity to advance drug approval under
the FDA's Animal Rule

• FDA confirms the Animal Rule pathway is appropriate for developing
countermeasures against Marburg

• FDA advises Galidesivir would qualify for a Priority Review Voucher (PRV) on
approval – PRV's command prices up to ~US$155m on the open market

• Clear guidance provided by the regulator on clinical program design – enables
Island to finalise plans ahead of trial commencement

• Island intends to commence the Galidesivir clinical trial program to advance
approval in Q1 CY26 based on program approval by FDA

• Responses significantly de-risk and accelerate regulatory pathway

• FDA provided important feedback and confirmed the strength of historical data,
including 94% survival in Marburg-infected primates versus 0% in placebo

• Underpins Island's strategy to position Galidesivir as a critical counter measure
against high-priority viral threats for inclusion in government stockpiles

• Island is concurrently advancing agreements with potential trial sites and
commencing US Government engagement initiatives

MELBOURNE Australia, 17 November 2025: Australian antiviral drug development
company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to
provide an update on positive responses from the US Food & Drug Administration
(FDA) to questions posed in a Type C Meeting Request regarding Galidesivir's approval
pathway for use in Marburg under the FDA's Animal Rule, as well as its eligibility for a
Priority Review Voucher (PRV) and pending clinical development initiatives.

The Company received written responses from the FDA on 12 November 2025 (US
time), which highlighted that the Animal Rule is an appropriate regulatory pathway for
approval of Marburg countermeasures. Further, the regulator has stated that
Galidesivir would qualify for a Tropical Disease Priority Review Voucher upon approval
under the Animal Rule. A PRV is one of the most valuable incentives offered by the FDA
and have previously sold on the open market for between US$100 and US$155m.
The FDA also provided valuable guidance on Galidesivir's clinical development
program to advance approval.

The Company has the opportunity to submit questions
to FDA by 2 December 2025 (US time) requesting clarifications on this feedback. This
will provide another opportunity to engage with the regulator and to optimise
Galidesivir's clinical program design for the best chance of approval.

[Max]

Congrats,Shareprice is up 23.5% today.Have just started researching bio stocks,dang!

[HAWKDOG]

here is a link to yesterday's webinar - I think ILA has a ways to move yet.

https://youtu.be/XH27oXin0Pg?si=Fa2vpyM7OU-RrpjI

[HAWKDOG]

Still holding ILA.

Next catalyst:

-Further FDA feedback expected early January 2026, guiding study design ahead
of a planned Q1 CY26 clinical program, subject to approval

[HAWKDOG]

latest presentation - outlining FDA pathway
https://youtu.be/clMeX30iwXs?si=ElHzdvDUZ0bPD7pQ

[HAWKDOG]

news out today - collaboration with the US army.  Which will likely be the main customer if it proceeds well through trials.