Elite Pharmaceuticals Inc (ELTP)

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Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q3 2016 Results - Earnings Call Transcript

"We do have capacity in the current manufacturing facility in order to make the product and for product launch. The facility today in its present form is sufficient to handle product launch for SequestOx. We will not manufacture launch quantities till we get closer to the launch date. Again we are a small company. I don’t want any surprises, I don’t want a question from the FDA, I don’t want any delays, and therefore we’re not going to take any chances and we’re going to wait. And to give you an example on here, Pfizer filed their Oxy BID and they got priority review and the FDA at the end of the prior review said we would need three more months to discuss it further and after the three months, they also needed some more time because has not disclosed. If we make launch quantities, it will be sure dated and will be about to expire, and we’re not going to take that risk. We will wait till all the events are lined up in our favor and then we will go ahead and make the launch quantities. The launch quantity should not take that long. Therefore it’s not really a showstopper, or not even a bottleneck."