Thanks Stano02. Slide 6 also predicts an on-market release of 12...

Thanks Stano02. Slide 6 also predicts an on-market release of 12 months.

Also look a slide 14 - 'Utilise accelerated development /regulatory pathways (i.e. 505b2) for optimal ROI'.

DRUG CANDIDATES WITH 505(B)(2) POTENTIAL
A company may wish to create a new dosage form that is faster acting, combines two active ingredients in a novel way, or provides a route of administration or mechanism of drug delivery that patients or doctors prefer over previous versions. Also, a company may wish to seek approval for a new indication for an already-approved drug or carry out an Rx-to-OTC switch. Such new products often contain well-understood active ingredients that are present in existing, approved drug products (reference drugs); so, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication. The 505(b)(2) NDA pathway makes this possible. In Europe, a regulatory approval route similar to the 505(b)(2) pathway is the hybrid procedure based on Article 10 of Directive 2001/83/EC.

BENEFITS OF 505(B)(2)505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
- Relatively lower risk because of previous drug approval
- Lower cost, accelerated development due to fewer studies
- May qualify for three, five or seven years of market exclusivity

I don't think i've seen this pathway presented by SPL before.