Replies to post #388327 on Elite Pharmaceuticals Inc (ELTP)

[JamesF1]

I agree everything has gotten more “non-specific and cagey”. Has the competitive landscape changed significantly since the 2017 press release? I don’t understand the reasoning.

[JamesF1]

Regarding the 2017 submittal, my understanding is the application was considered incomplete because insufflation studies were not done at that time.

[jour_trader]

It has been previously discussed in cc’s that the generic Oxy was held up due to insufflation studies that have now been completed w/ partial filing made mid-year to get PDUFA date going until full application could be filed. I think all filers received CRLs from 2017. All signs point to this being the Oxy filing. Nasrat has mentioned the potential legal hurdles with Purdue and first to file process (probably not us). Don’t think it’s Norco.

[NASDAQ2020]

Agreed something is not adding up. Why would Elite File THREE times for OxyContin generic.
(1.)2017 OxyContin
(2.)Aug 2023 OxyContin
(3.)and sept 2023 an Opiate Analgesic Product
First two times it was called OxyContin today called it an : Opiate Analgesic Product not OxyContin
may be its the same opioid with or without ADF or some different formulation
OxyContin is a 12 hour
also thinking out loud.
When I saw PR this am I did not think it was OxyContin until the Market size was noted.
Still not sure

[WeeZuhl]

so why file an entirely new application in August 2023?

https://www.fda.gov/industry/generic-drug-user-fee-amendments/frequently-asked-questions-how-gdufa-affects-abbreviated-new-drug-application-anda-submissions#Q2

Q2. What happens if FDA identifies deficiencies in an ANDA?
...
The sponsor may decide to submit additional materials to correct the deficiencies, but the resulting amended ANDA will be considered a new ANDA submission, received as of the new date, requiring a new GDUFA fee.
...

[The ELTP King]

You're so phuckin' dumb.

Thankfully, kayak_wench saved me the time of embarrassing you:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172897758


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