Bad news for exparel

[urge]

No Exparel in Europe to my knowledge i suppose once it get's full FDA approval they will start marketing it here.

That does not make sense.

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[dhb]

Sorry to bring you such devastating news

 

[BuzzPhreed]

I think what he meant is that the EMEA approves drugs in Europe. It is completely separate from the FDA. In fact, while they look at the same studies they couldn't care less about the FDA's decision(s) and certainly don't follow their lead.

Historically new medications are approved and marketed well in advance of FDA approval in the U.S. It is a rare drug/medication where that happens the other way around.

It may come as a bit of a shocker, but most of the rest of the world doesn't hold the U.S. quite in the same high esteem as we seem to do ourselves.

 

[deleted126335]

• Reaffirming our wide moat and stable moat trend ratings. Alibaba's recent top-line growth trends have been supported by an increase in the number of active buyers and sellers, supporting the network effect underpinning our wide moat rating. We continue to believe that structural differences in China's retail industry and Alibaba's mobile investments will protect its network effect, even as China moves from a consumer-to-consumer to a business-to-consumer e-commerce market, resulting in a stable moat trend.
• Our $90 per ADS fair value is based on a revenue CAGR of 32% and operating margins expanding to 50.2% from 47.5% over the next five years. Our top-line assumptions are due to several macroeconomic, socioeconomic, regulatory, and industry growth drivers, while a scalable third-party platform should allow Alibaba to generate margins well ahead of its peers.
• Assigning Alibaba high uncertainty and poor stewardship ratings. We've assigned a high uncertainty rating based on competitive, regulatory, and execution risks, while our poor stewardship rating balances management's solid execution with concerns about its variable interest entity (VIE) structure, partnership committee, and Alipay transference.

Conservative IPO Pricing Range Underappreciates Alibaba's Longer-Term Potential, but Investors Must Understand the Risks

BABA is under the IPO date closing price.

 

[Mman]

While Pacira is yet to become profitable on an annual basis, its forward valuation looks compelling given the margin expansion potential and the likelihood of triple digit earnings growth in the next two years. Pacira currently trades at a forward 2015 P/E ratio of 35, which is low considering the expected earnings growth rates in the next three to five years. I believe that a forward P/E ratio of 50 or higher is justified given the expected growth rates. I am maintaining my $145 price target which was based on a 2015 P/S ratio of 15, which roughly coincides with a forward 2015 P/E of 50. If we take a longer term view, I believe that the upside potential is still in the triple digits.

No offense to Blade. Lots of people with much more training and intelligence than me throw these sorts of terms out there.

When they say...what I read
"is yet to become profitable"..."still losing money"
"the likelihood of triple digit earnings growth"..."the remote chance"
"forward P/E ratio"..."wild ass guess of predicting the future"


The market crashes of 2001 and 2008 were both preceded by all sorts of hot companies being traded at sky high numbers on the basis of growth rates and forward P/E ratios.

 

[BLADEMDA]

No offense to Blade. Lots of people with much more training and intelligence than me throw these sorts of terms out there.

When they say...what I read
"is yet to become profitable"..."still losing money"
"the likelihood of triple digit earnings growth"..."the remote chance"
"forward P/E ratio"..."wild ass guess of predicting the future"


The market crashes of 2001 and 2008 were both preceded by all sorts of hot companies being traded at sky high numbers on the basis of growth rates and forward P/E ratios.

PCRX is expensive at today's Earnings. But, if or when the FDA approves Exparel for Femoral Nerve Blocks the stock looks cheap as sales will double from here.

I don't own PCRX but would be a buyer at $80.00

 

[BLADEMDA]

 

[BLADEMDA]

I don't own Alibaba as don't trust the Chinese period. I own 2 Asian Mutual funds in my 401K and let them deal with it. As far as Alibaba is concerned please read this:

http://www.zerohedge.com/news/2015-...o-bought-baba-stock-and-held-now-losing-money


I think alibaba will eventually recover somewhat but I don't trust the Chinese period.

You guys keep misquoting me as though I'm buying all these Individual stocks when I prefer ETFs. I am looking into the Energy sector (adding to my recent purchases in December) and may buy a few individual names recommended by Morningstar as long term plays (undervalued, long term plays).

 

[BLADEMDA]

PCRX around $70-$75 is a good entry point. That price point will likely result in 100 percent gains in 24-36 months.

I still think $80 or less is a good entry point for PCRX and I would be a buyer at that number. I believed in the drug and see it taking market share once/if it gets FDA approval for nerve blocks.


Yes, it is a gamble as to whether it ever gets FDA approval which is why it should be trading at under $80 this month.

 

[Oggg]

It's not better than bupi. It is an absolute waste of money.

I thought a new drug indication just had to show non inferiority these days.

 

[Oggg]

That is the point - it totally replaces a catheter. Catheters are a huge pain to take care off and manage. On-Q pumps are almost twice the cost of exparel. Placing catheters are tricky.

I still think it is absolutely nuts that a pump company (On-Q, Stryker) hasn't bought Pacira.

I can't believe that no pump company has come up with something cheaper and simpler than the On Q. Baxter used to make a simple bottle with a ballon inside, fixed rate of 5 or 7cc/h, for $50.

 

[Pooh & Annie]

I thought a new drug indication just had to show non inferiority these days.

That's a different subject altogether.

 

[Mman]

I have no idea but I'd imagine getting an indication for essentially a different route of administration (perineural vs subcutaneous or intra-articular) is a whole different animal compared to a pill that you swallow that works on one thing and might also work on another. Probably need both safety and efficacy data for the new route of administration.

 

[BuzzPhreed]

Exparel will eventually go down in flames and no longer be used. Mark these words.

 

[epidural man]

Exparel will eventually go down in flames and no longer be used. Mark these words.

Marking....

 

[BuzzPhreed]

I'm just making a prediction. I'll eat my words if I'm wrong. All the data I've looked at tells me it's smoke and mirrors. First death or major complication... first major lawsuit... dodo bird.

These are the same folks who brought you DepoDur. Anyone still using that? Didn't think so.

 

[BLADEMDA]

Exparel is a good drug and it is superior to Bupivacaine with Decadron for single shot blocks. The question is will hospitals pay $275 more for Exparel vs Bup with decadron?

I like Exparel and will continue to use it.

 

[Hoya11]

Is there any real data on exparel efficacy vs bupivicaine? (besides the company sponsored study with non-stastically significant pain scores and days to discharge differences ever so slightly in favor of exparel?) and now they can not even prove it better than placebo?

I ask because surgeons at my gig use it for infiltration and refuse any pre/post-op nerve blocks, and since this started ive seen seemingly more pain in patients post-operatively, though honestly some do fine. There is always one a day that is a nightmare. Just curious if there is ANY real data supporting its use.

 

[epidural man]

Is there any real data on exparel efficacy vs bupivicaine? (besides the company sponsored study with non-stastically significant pain scores and days to discharge differences ever so slightly in favor of exparel?) and now they can not even prove it better than placebo?

I ask because surgeons at my gig use it for infiltration and refuse any pre/post-op nerve blocks, and since this started ive seen seemingly more pain in patients post-operatively, though honestly some do fine. There is always one a day that is a nightmare. Just curious if there is ANY real data supporting its use.

There will be. I know that from a scientific standpoint - you get blood levels of bupivicaine for 3 days - so it certainly is slowly releasing as they claim. This is the first step - does it do what we think - that is...does it release bupivicaine over time. The next question...does it matter? does a slow releasing deposit of local anesthetic make a difference when placed in a surgical site or near a nerve.

The data will come - good or bad.

Our retrospective will be published eventually. We have shown decreased hospital length of stay and ICU stay, huge hospital savings, and surprisingly, a dramatic decrease in the use of thoracic epidurals.

 

[psychbender]

Our retrospective will be published eventually. We have shown decreased hospital length of stay and ICU stay, huge hospital savings, and surprisingly, a dramatic decrease in the use of thoracic epidurals.

Our CT surgeons use exparel for intercostals before reexpanding the lung, and the patients are remaining almost pain free and normotensive for the first two to three days. Now, I only get to put in thoracic epidurals for open thoracotomies. Only one orthopedic surgeon has managed to show a real difference with exparel in his total knees, the others all still make a lot of use of PCAs/prns, but the surgeons now are not interested in any form of regional, because they used the magic white drug the reps told them was awesome.

 

[Noyac]

Are any of you placing rescue blocks ever for these TKA pts?

 

[Hoya11]

You put in thoracic epidurals for VATS? Way before exparel thoracic epidurals were only for open thoracotomies.

And you cant do rescue blocks for these patients because of the packaging instructions with exparel that says no other bupivicaine or ropivicaine once exparel is in the picture. So once the spinal wears off its the exparel or nothing, and there is usually a window period between spinal wearing off and exparel starting to work (if it works). I have considered a lidocaine catheter but surgeons freak.

Also, what is the motivation to listen to the reps? Are they being paid to use exparel directly or indirectly?

 

[Noyac]

^^^exactly but I'm getting the impression that some are still placing rescue blocks.

 

[Arch Guillotti]

And you cant do rescue blocks for these patients because of the packaging instructions with exparel that says no other bupivicaine or ropivicaine once exparel is in the picture.

What's the difference between placing an adductor canal block preop versus postop?

 

[psychbender]

You put in thoracic epidurals for VATS? Way before exparel thoracic epidurals were only for open thoracotomies.

And you cant do rescue blocks for these patients because of the packaging instructions with exparel that says no other bupivicaine or ropivicaine once exparel is in the picture. So once the spinal wears off its the exparel or nothing, and there is usually a window period between spinal wearing off and exparel starting to work (if it works). I have considered a lidocaine catheter but surgeons freak.

Also, what is the motivation to listen to the reps? Are they being paid to use exparel directly or indirectly?

We used to put in thoracic epidurals or PVBs for VATS (yes, a little overkill) I liked it, as the patients were very comfortable afterwards, and it kept my skills up. Now, not so much. I'm in the military system, so there is no financial incentive on the part of the surgeons to use exparel.

The package insert actually says to limit the bupivicaine dose to 1/2 the exparel dose, if used in addition to the exparel. Considering I do rescue blocks with 0.125-0.2% bupivicane, that works out just fine.

 

[Hoya11]

You put in thoracic epidurals for VATS? Way before exparel thoracic epidurals were only for open thoracotomies.

And you cant do rescue blocks for these patients because of the packaging instructions with exparel that says no other bupivicaine or ropivicaine once exparel is in the picture. So once the spinal wears off its the exparel or nothing, and there is usually a window period between spinal wearing off and exparel starting to work (if it works). I have considered a lidocaine catheter but surgeons freak.

We used to put in thoracic epidurals or PVBs for VATS (yes, a little overkill) I liked it, as the patients were very comfortable afterwards, and it kept my skills up. Now, not so much. I'm in the military system, so there is no financial incentive on the part of the surgeons to use exparel.

The package insert actually says to limit the bupivicaine dose to 1/2 the exparel dose, if used in addition to the exparel. Considering I do rescue blocks with 0.125-0.2% bupivicane, that works out just fine.

huh wow i must have missed that part, thats great! our surgeon demands spinals, but a pre-spinal FNB should be an option with 25ml 0.5% or equivalent. thanks for pointing this out.

 

[Baller MD]

This thread is great, LMAO.