Pharmascience Inc. v. Meda AB et al - Nov 16, 2021 - Part 2
3:39PM Nov 16, 2021
Speakers:
Keywords:
pms
noc
turn
launch
scroll
chance
exhibit
morning
reference
market
timeframe
evaluation form
estimate
commercial
mark
reg
document
days
april
narcotic
Do we have counsel with a son that was spared? Okay, recording in progress was my result. Thank you. I'll come back Misha. Go My name is Chip. Um, I would like to start by turning it turning out one of the productions you looked at with counsel this morning, and it is exhibit eight, PMS 136. Just take a moment here to get our share screen rolling. And, and you spoke this morning about this document, but I just want to take a look at the section that says launch assumptions. And in there's the launch at reg approval estimated as of April 14, then there's a reference to could be first or second to market. So at the time, you're anticipating the potential for generic competition.
It's a possibility because there are no patents on their register. We don't have visibility to other activity competitive activity.
And if we can turn up PMS Production Production 135 Or sorry, 137. My apologies. And I don't believe you went to this one this morning. But do you recognize this document Ms. Ship?
I do. It's called commercial evaluation form. It's completed, it's filled out before product goes to the commercial stage.
Thank you and I'd like to mark this as the next exhibit. I believe it might actually be our first one.
What what is what's the FC number?
196 FC one nine.
FC196 will be exhibit 22.
And we can see here if I can ask to scroll down a little that as of October 2013, the -- still predicting a launch in April 2015 after receipt of an NOC in March 2015 as of this timeframe?
that's correct.
And if we can turn to page eight of this document, please. Sorry, you may have to zoom out a little or if you can scroll down on on page eight.
And if you see, there's the section "Forecast Reports". And there's two scenarios, and there's reference to "Launch 1st to market at reg approval" being a 50% chance, and "Launch 2nd to market" being a 50% chance. So again, anticipation of potential generic competition as of this time in
2013. It's a possibility Yes. Well,
and in fact, it's, you've pegged it at a 50-50 chance that someone may beat you to market.
The reason we put 50-50 is because we don't know. So that was the reason for that.
And if we could turn up PMS production 143, which is -- which was marked as Exhibit 11, I believe. And I believe as of this timeframe, if we scroll down, we'll see the same reference to a 50% chance of being first to market 50% chance of being second.
Yes.
And if you could actually scroll back up, please Miss Torrance. Okay, that's. And we see there's a reference in the projected launch date. And I believe you discussed this briefly this morning, to NOC plus five days for narcotic lock license. And I just want to clarify, confirm that's five business days, right.
That was the assumption Yes. The quickest possible would be five business days. Idon't know if that's the quickest possible that was the estimate we use.
And then if I could ask to turn up at PMS, 144. And I don't believe this was looked at this morning. So I'll give you a moment, Ms. Ship. Do you recognize this document?
I do. It's the stage report for Zolpidem passing the submission date.
And I would ask that we mark this at the as the next exhibit and it's FC number is 203
