Sparks Valuation Pharmaust, page-5

When looking at a biotech company with plenty of promise, Atlas Funds Management says one of the signposts it looks for is how close the company’s drugs are to an FDA approval.

“Looking at where a company’s treatments are up to in the US’s FDA approval process will indicate the level of investment risk,” noted Atlas.

What moves the needles and gets Aussie biotech investors excited is the news of some sort of approval from the US FDA.


The FDA is the ultimate gatekeeper for the US pharmaceutical market, which is by far the world’s largest.There are five applications and approvals that the FDA can provide a company with:Investigational New Drug (IND)New Drug Application (NDA)Abbreviated New Drug Application (ANDA)Over-the-Counter Drugs (OTC)Biologic License Application (BLA)

An FDA approval also gives the biotech a competitive edge, because it grants the drug exclusivity for a certain period. In the case of a new drug, this exclusivity period means that generic competitors cannot enter the market.

There’s also partnerships and licensing opportunities that an FDA approval can potentially attract.And last but not least, an FDA approval badge boosts investor sentiment and confidence in the company’s prospects.

The US FDA has granted PharmAust a Pre-Investigational New Drug (Pre-IND) meeting for monepantel, for the treatment of motor neurone disease/amyotrophic lateral sclerosis (MND/ALS).

The request was submitted on 15 December 2023, and the FDA has committed to provide written responses by 13 February, 2024.

PharmAust says the request for a pre-IND meeting formally initiates communications with the FDA regarding developing monepantel to treat MND/ALS.


The pre-IND meeting aims to confirm the details and acceptability of PharmAust’s proposed ongoing development program, including the requirements for non-clinical and clinical pharmacology, clinical chemistry, and manufacturing controls.

Importantly, and given the stage of development of monepantel for the treatment of MND/ALS, it provides PharmAust with an opportunity to seek feedback from the FDA on the design of its planned Phase 2/3 adaptive clinical study and gain insights into the FDA’s requirements for monepantel to be potentially granted accelerated approval.

With these considerations in hand, PharmAust says it will be able to proceed confidently with its full IND application filing in Q2 2024.

Ref : Eddy Sonarto St...head.com.au 19/01/24


Kpax ( enjoying the ride)