35-40 Cents base case. Here's why., page-5

Hi Nikki,

I respectfully disagree.

See the investor presentation released recently Slide 3. They have hinted at ARP. Usage of word Potential. So the announcement you suggested has been superseded by the one I am putting forward.

Also note the FDA website suggesting

According to the U.S. Federal Code of Regulations (CFR), the definition of a biologic is “any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man.”5 Biologics were first developed in the 1980s using recombinant techniques to copy or improve on naturally occurring complex peptides, proteins, and glycoproteins.1,3,4 Since then, even more complex products, such as monoclonal antibodies, have been produced through the manipulation of the DNA in bacteria, yeast, or mammalian cells to produce therapeutic or diagnostic agents.1,6–8

Note the increasing usage of word IGF-1 analogue in the recent presentations. Also note that they provided the science behind the product. They should get ANDA but NEU may have been consulted to file for PHSA.

Biologics are much more complex than conventional “chemical” drugs because they are larger and have more complicated structures (Figure 1).5,7,8 Many biologics have become increasingly well characterized, including their mechanisms of action.3 The structure–function relationships of biologics are very sensitive, because modifications of primary or higher-order (secondary, tertiary, or quaternary) configurations may affect safety, purity, and/or potency.6 During the manufacturing process for biologics or biosimilars, primary amino acid sequences can become modified through glycosylation, changing the shape of a protein because of alterations in the way it folds.5 These post-translational modifications are not controlled by the recombinant DNA inserted into the host cell but are affected by the cell line and the environment in which the cell line is grown.3

Traditionally in the U.S., biologics are approved under the Public Health Service Act (PHSA), whereas conventional chemical drugs are approved under the Federal Food, Drug, and Cosmetic Act (FDCA).2,3,5Under the PHSA, originator biologics receive approval through a Biologics License Application (BLA), also known as the “351a pathway.” This process requires significant preclinical and clinical data to prove the efficacy, safety, and quality of the agent.2,4,5 In 1984, the Hatch–Waxman Act amended the FDCA to include expedited 505(j) and 505(b) (2) regulatory pathways, which allow generic chemical drugs to be approved through an Abbreviated New Drug Application (ANDA).3 By contrast, the PHSA does not define an approval process for biosimilars.2,5

Regarding the valuation, a mathematical model may not necessarily fit a drug discovery company as they have no revenue. However, one must only look at all the trials conducted in this field and gauge the historical market reaction to arrive at a valuation.

I will post a detailed post in the future.