Replies to post #318545 on Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

IR opioids not effected.

[NASDAQ2020]

The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that are on the market today. To achieve this goal, FDA is taking steps to incentivize and support the development of opioid medications with progressively better abuse-deterrent properties. These steps include working with individual sponsors (companies) on promising abuse-deterrent technologies; developing appropriate testing methodologies for both innovator and generic products; and publishing guidance on the development and labeling of abuse-deterrent opioids.

[WeeZuhl]

This is a significant roadblock for any company developing opioids

I take this to mean no new opioid approvals until further notice, at least in regards to NDA's. This PR is coming from IPCI and not FDA, but these words are in quotes, presumably from a letter from FDA: “is postponing product-specific advisory committee meetings for opioid analgesics,” ... “while it continues to consider a number of scientific and policy issues relating to this class of drugs.”


No AdComm --> No approval

The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.

This is probably good for IPCI. They could have been torn up at AdCom for most likely poor results on chewing HAL studies, with subsequent CRL crash. But now the application goes to purgatory. Instead of a two-time loser, they still have a potential asset in the form of a pending NDA, for who knows how long.

An interesting coincidence(?): on July 22, FDA approved the first nine ANDA's for generic Lyrica, a non-opioid analgesic.



Go ELTP.
Long & Strong.