Elite Pharmaceuticals Inc (ELTP)

[Winechemist]

Good morning James, I had previously alluded to how long it takes for a launch in a previous email. Anticipate 2-4 weeks post approval for the API to come in and be released, then they need to schedule a total of 3 process validation commercial scale batches. There is a lot of paperwork associated with these. Anticipate another 4 weeks for this to be performed. Then all of the samples need to be tested and all of the validation reports signed off by QA so another 4 weeks. To be conservative once approval is given if they did not have everything in place, which most companies do not as you never know when FDA approval will come, I would anticipate about 3 months until official launch of a drug product. Based on my estimates I would anticipate launch of this one sometime middle to end of August. Once again this is conservative, and timelines can always shift or be sped up but this gives everyone an idea of time to launch. Cheers