LNTH
#Absolutely.
So, <UNK>, this is a little bit different because if we look at the quarter-over-quarter growth, there's a very strong dynamic from that versus a slightly different dynamic if we look year-over-year.
So let me speak first to quarter-over-quarter.
The most dramatic change between fourth quarter of '15 and Q1 of '16 is our contracting strategy.
So as of January 1st, we now have contracts with all four of the major radiopharmacy chains in the United States, and those contracts specified committed volumes of TechneLite and other key nuclear products for us.
So that's what is really driving that quarter-over-quarter performance.
And in similar vein, the year-over-year performance, the addition of the contracted customers is also driving that.
As I mentioned in the call, we now have contracted committed volumes for TechneLite and in our other key nuclear products with all four of the radiopharmacy chains; so that what you see driving that.
In first quarter, we had, as <UNK> and I both referenced in the call, some further incremental sales of TechneLite where we were able to supply our customers beyond their committed volumes because in short notice, they came to us with extra need and asked if we could fill in that extra volume for them, and we were happy to do that.
I can only offer you the color, <UNK>, that it's completely unpredictable.
So, I think the way for you to think about our nuclear business is with our contracting strategy now fully executed, we have a very good line of sight for minimal committed volume across our key products.
We look to fill that in by meeting customers' extra needs.
However, those needs come to be [cause] whether if it's a market disruption or something else that's happening, somewhere else in the channel, we're always happy to step up and offer our customers with quick notice even additional product that satisfy what they need in their market.
So, I can't give forward-looking guidance on a specific product.
I think as we report Q2 and beyond, you will see then for our key products, for DEFINITY, TechneLite, and Xenon, you will see the quarterly revenue performance for each of those products.
I did understand your question, <UNK>.
And I chose my answer carefully.
I will not comment specifically on what the overperformance was because we don't give quarterly product level guidance.
Sure, <UNK>.
Thanks for joining the call.
The way I will respond about China is, the best I can do <UNK> is cite what the Chinese FDA publishes as their estimated time lines for each portion of the approval process.
So we're currently in the ---+ CTA has been approved.
We're in the portion of the process during which the trials are done.
By their website what they estimate a fair amount of time to consider here is approximately six months.
And the reason is compared to if we think about the U.S. market, these are small trials and they're meant to be confirmatory and not exploratory, and so they are easier to get through.
Post that, once those data are completed and then included in the application, the final phase of the program for the Chinese FDA is actual IDL or Import Drug License approval.
If we look at the time lines cited by the Chinese FDA and we apply those to our current program what we estimate is that our product could be approved for commercial sale as early as the end of 2017.
In actuality, we have seen a program really kind of hit along the published milestones with a little bit of flexibility.
And so, we're encouraged that the program will continue on the expected milestone.
Yes, <UNK>.
And you're right, it was $8 million for the quarter.
And the primary driver of that quarter over last year's quarter is the pricing related to our contracting strategy.
And you're right, that we did not see any impact of the competitor in Q1 that we have baked the expected impact of that competitor throughout the rest of our guidance.
I would think that's probably a fair high level way to look at it, but really the guidance reflects the breadth of all of our products not necessarily just the DEFINITY growth.
So when we updated the guidance both the revenue and adjusted EBITDA, we did consider the margin.
Not a significant shift is expected in expenses from what we thought at the beginning of the year, so I think your assessment is at a high level directionally correct.
<UNK>, thanks for joining the call and thanks for the question.
I think what we're trying to signal with flurpiridaz F 18 is that, versus our last comment included in the last call, we've got active progress forward.
And you're right, one of the key parts that will come out of this partnership is the funding of the second Phase 3 clinical trials.
And we look to have that commence as quickly as possible once we announce and finally execute the partnership agreement.
At this time, I'm not going to offer a program date for approval of the product.
I think it would be premature and I really wouldn't guesstimating.
So I'm not sure that that would be essentially helpful to you with your modeling.
<UNK>, it's <UNK>.
We have a policy, we just are not providing forward-looking product level guidance and revenue, and so I appreciate the challenge.
I guess the way I'd look at it ---+ I think <UNK>'s comment was directionally accurate.
We saw great growth in DEFINITY over the quarter and some other TechneLite favorability.
We're now modeling Xenon for the rest of the year.
So thinking at a high level, you kind of do the math with DEFINITY, Xenon, and some of the other products favorability, I think you can get there.
And I think as you see the second quarter revenue by product results that will help your model for the rest of the year.
