Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

In my opinion it makes zero sense for a company to have to repeat costly tests just because they chose not to market a drug. Between the FDA documentation and common sense I choose to conclude that WeeZuhl is mistaken in his opinion.

As a general rule for pharmaceutical investors, it is not the common sense position to think that any FDA process is going to be quick or easy. Read the links. Moving a drug from the discontinued list to the active list requires an official back and forth process with the FDA. Even the simplest of examples will be on FDA's timeline, not the manufacturer's. If it has been a significant amount of time since the drug was discontinued, or if *anything* has changed, then a supplement will be required, which is even more time waiting for an FDA response. Small stuff could be submitted in a straightforward CBE-30, but anything substantial, like a change in API, change in facility, change in process or storage, new inactive ingredients, etc, etc, will require a PAS. If a PAS is required, the company may not move forward with marketing until they receive approval, which as I said before, the timing of a PAS approval from FDA would be along the lines of an original full ANDA approval, more like 10 months than 2 months.

What I will add to my previous post is that the FDA expects a company to do something with an approval within 6 months. If the drug is not on the shelf by then, the FDA expects the company to declare their intentions at that time. A lot of drugs are moved to the discontinued list around the 6 month mark. In my opinion, if a company had an upcoming marketing date, they would give that info to the FDA at that time, instead of discontinuing the drug. By corollary, if a company moves a drug to the discontinued list, then that strongly suggests to me that they do not yet know for certain when they will be able to market it.

I think the real common sense position here is that a company would want to avoid discontinuing an ANDA if they knew for sure the drug was going to be marketed in the next six months. You can take it for whatever it's worth- my opinion plus $1.50 will get you a ride on the local bus. Also for what it's worth- I'm still surprised Lannett terminated the Adderall agreement, and I still think it was a bad move for them, especially at this time.

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