Cassava Sciences Inc (SAVA)

[realfast95]

This is the letter the FDA gave PTIE and DRRX on 9/8/16

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM520687.pdf


The key part is as said in this tweet

$PTIE and $DRRX trading off this: "FDA says Remoxy ER doesn't qualify for FD&C Act exemption." Not sure what this means if anything

https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

in english
The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form[4](see elixir sulfanilamide disaster). It replaced the earlier Pure Food and Drug Act of 1906.

So this is the primary point of contention. Are they exempt or not
FD&C Act

If they are not. It means a new study IMO