Solid post and why it is a sticky note- it bares repeating and why change is coming- and it ain't the .02 but $2's.
Two things ought to be clarified here based on recent posts...
Efficacy studies, if needed, are not a surprise. The FDA has been burned by every ART/ADT product thus far and are just protecting themselves downstream if is something happens. That said, nobody knows if the FDA has even gotten back to Elite since the 11/18 meeting. What we do know is that Elite is ready to file and they will not do so until they hear back from the FDA that they meet the filing requirements. This is a very smart approach to filing and we can thank Carmargo -- who has prior FDA reviewers and staffers on its' own staff -- for such guidance. The filing could happen at anytime. If Elite is required to do an efficacy study, the study design and plan has been prepared by Elite, Carargo and CFI Lifetree. This study should take three months at most and does not impact the actual timeline for final approval. In addition, Elite has been told they will receive designated expedited review from the FDA. Things will move very fast. Most importantly, all the prior BE data data tells us the efficacy studies will be successful. These are very well known, clinically acceptable analgesics, pain relievers and an opiate antagonist that have been used for decades. The FDA knows this, because they have approved each one. Lastly, the positive HAL studies will tell us why the this delivery system will be embraced by the clinical community and penetrate this market rapidly.
In regards to Elite's generics. The majority of those will never be produced and it has been and still is posturing. A couple decent money makers are certainly lined up (Isradapine and TBD) to ensure cash was coming in while they worked on their first submission, but I believe after Elite secured the financing they needed, the majority of generics were truly put on the back burner. People harping on these generics are missing the bigger picture of why Hakim was brought on board at Elite. For those that cannot connect the dots, I will simplify it, for the full story is complicated, years in the making and spiderwebs to many places. But to put it simply, he is here to launch a full line of abuse deterrent painkillers. The first of those will be filed soon and approved and the set the stage for a little unknown company to jolt the pharma industry.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
