Elite Pharmaceuticals Inc (ELTP)

[Hike]

We have plenty of data. Whether in the eyes of the FDA we have sufficient data to avoid an additional trial for efficacy remains to be seen. In addition the FDA will want a pediatric study. The question there is will the FDA allow Elite to conduct that study after filing their NDA or before.
If after any approval can be contingent on satisfactory pediatric study results. That would be ideal as it would not slow us down. If the FDA requires an efficacy study that could delay filing of an NDA for a good 6 months.

We are all waiting to hear from Nasrat if/when he has or will meet with the FDA and what the FDA had to say about any additional trials.