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Re: rafunrafun post# 273591

Wednesday, 05/20/2020 6:53:45 PM

Wednesday, May 20, 2020 6:53:45 PM

Post# of 423952
I received an alert this afternoon that a transcript of Dr. Reddy’s earnings conference call was available to read. I found the following interesting, if not informative:

1) Dr. R is waiting to hear from FDA on pending approval of 97 ANDAs now on file.

2) in Q&A, Neha Manpuria (JP Morgan) asked:

....”My second question is on generic Vascepa. Post litigation win at the district court, just wanted to get a sense on where we are in terms of the product with the FDA?”

3) Erez Israeli:

“So it’s a great win for us. And we believe that this is a product with a lot of potential.
And right now, and as you know, there is still a legal process in there, and we are walking(working?) toward exploiting the potential of this one.

4)Neha Manpuria:

“But do we have a target action date on this? Or is there a CRL on this from an FDA perspective?”

5) Erez Israeli:

“There is no regulatory issue on this one.”
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