Elite Pharmaceuticals Inc (ELTP)

[Investintin]

the powerful groups that are keeping ADFs off the market

I'm afraid the answer is more simple and boring than conspiracy theories involving 'Big Pharma' and powerful groups... it is simply because the science of ADFs is relatively new and FDA does not know what will work and what will not, and how to evaluate that:

Because the science of abuse deterrence is still evolving and the agency does not yet know which technologies will ultimately prove most effective in deterring opioid abuse, the agency believes that it is in the interest of public health to encourage development of multiple abuse-deterrent alternatives while continuing to promote and protect innovation.

https://www.fda.gov/Drugs/DrugSafety/ucm535708.htm

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM545923.pdf


FDA just recently appointed a scientific commission that will be helping with reviewing of ADF NDAs... and even with the guidelines published in 2016 and the commission, the data required to prove an ADF works is being debated - companies want to submit the minimum and scientists/reviewers are asking for more.


Regarding generics, I have said it before that FDA is encouraging their development but they will not rush to approve them until the post-marketing studies of branded ones are completed (due by the end of 2018 and mid 2019)


In interest of Elite, IR opioids will be scrutinized even more, due to the obvious implications, REMS in place and historic issues.

So again, don't expect the "20 Catalysts" to be approved any time soon...