35-40 Cents base case. Here's why., page-7

Hi Nikki,

I must again respectfully disagree.

FDA amended their BLA to include peptides and proteins and consideration will be given to existing product trying to make it to the market. The date is set to 23 march 2020. So fair to say that NEU should be able to get in. Read this document specially page 12.

(Proposed Answer): The BPCI Act amends the definition of “biological product”
in section 351(i) of the PHS Act to include a “protein (except any chemically
synthesized polypeptide)” and provides that an application for a biological
product must be submitted under section 351 of the PHS Act, subject to certain
exceptions during the 10-year transition period ending on March 23, 2020,
described in section 7002(e) of the Affordable Care Act.

Source

I am unable to pull out the document that mentions possibility of Pediatric therapy designation but that term popped up in one of the presentation as well.

You can refer to this document explaining why IGF1 (GPE) can be classified under biosimiliars as being a peptide.

Note neuren's presentation stating - NNZ is the same class of peptide with higher bioavailability and potential for solid dosage form.

There are some interesting qualifying criteria regarding compounds above 40 amino acids size but I need more research to validate 100% if we fit in. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges. IGF-1 has a molecular weight of 7,649 daltons. Hence all the people worrying about IGF-1 as competitor , NEU has some solid 3-4 years bridge gap and advantage over them.