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The ELTP King

09/23/20 3:28 PM

#344609 RE: WeeZuhl #344583

1. Your thoughts on Arbor Pharmaceuticals beating Elite to the punch?

2. Just wandering if you have your pop and popcorn ready for November 15?

PDUFA target action date: November 15, 2020

— AR19 formulated with physical and chemical barriers against misuse

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158378642

"If approved, AR19 would be the first-ever immediate-release option that reduces the risk of being misused or abused by snorting, smoking or injecting, making it an important advance and potentially part of a comprehensive harm-reduction strategy," said Faraone, who is program director of ADHD in Adults.


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The ELTP King

09/23/20 3:43 PM

#344610 RE: WeeZuhl #344583

Good post. That's why I said to contact the company directly.

They have a phone number and an email on their website.

Also, 3 of the 5 ANDA's were actually sold in on February 2020, not in November 2019. So that's even less time to go through the FDA process to get them to market.


Sale of ANDA for Hydromorphone HCl oral tablet – 8mg

On February 3, 2020, Elite sold the ANDA for generic Hydromorphone HCl 8mg tablet to Nostrum for cash consideration totaling $300,000


Item 1.01 Entry Into A Material Definitive Agreement.

On February 20, 2020, the Company executed an agreement with NostrumLaboratories Inc. (“Nostrum”) pursuant to which the Company will sell to Nostrum all of its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Dolophine® (methadone hydrochloride tablets, 5 mg and 10 mg) and generic Bontril PDM® (phendimetrazine tartrate tablet, 35mg) for $600,000 in cash. The sale has been consummated.


It is unrealistic to expect Nostrum to commercialize multiple ANDA's within a year of acquiring them (Nov 2019)