Elite Pharmaceuticals Inc (ELTP)

[dest_golf]

This does not sound promising…
The API supply, supplier had issues with the DMF. We are not allowed to see the DMF.

We only give, FDA authorization to, look at the EMF and approve it after the vendor lets us do that. So FDA does, once the FDA looked at it and noticed some problems, they updated us and so did our supplier. They said that they have some issues with us. Our application, to the best of my knowledge, and as per FDA, did not have any issues with it. So now, all observations by the API supplier have been addressed.

We have evaluated them and they look adequate, and we believe the FDA will find them adequate as well. If the FDA does, then approval come in next week. If it doesn't, there is nothing that I've seen that looks like it's major. It will be a minor amendment that we will work with FDA