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Looks like Irma is headed your way now - hoping you dodge her and come out with your family and everything else intact. Post as soon as you can after the storm has past and let us know that all is well.
You are right in that it appears the current offer has not yet closed. But you have to admit it is not exactly a hot, oversubscribed offering. It is perfectly clear from the weak previous offering and slow start to this one that the company is in financial difficulty. And that means shareholders are at risk. I have to credit management with being able to hold things together so far but they really need to pull a rabbit out of their hat at this point to keep current shareholders from getting hammered.
One reason the current offering may be going slowly is that potential buyers might reasonably be asking why they should buy under the current terms when insiders got to buy a more attractive deal on the last offering?
If they raised the whole $15 million at the current price, that would have to be thought of as a great victory as the dilution would be relatively minor in relation to the consequences of the money not being raised or it being raised at a much lower share price (thus much more dilution).
The company actually faces two binary, if related, events. They need to get a successful meeting with the FDA on 10/12 (and who knows when the results of that meeting will be finalized). And they need to raise a lot of money to keep operating. If they fail at either CYDY shareholders are toast.
So, now we have two failed offerings in a row. If the bulls are not freaked out now, you never will be. The company does not have enough money to continue. How is it going to get the money it needs to complete its trials? Hopefully, some pro-HIV patient group compels someone to put the money up. Maybe some kind of foundation? Charlie Sheen might be able to help and he has an incentive to do so. But it is obvious the company needs to find a new source of funds and these delays and open questions with the FDA are not helping them at all. Had the PE results been out by now, it might be different.
It is entirely possible the money just raised will go to meet bills already incurred. It is white knuckle time. But I have to believe PRO 140 does not just evaporate into thin air. Some financial solution will be found to keep the drug going but it might not be one that does anything for shareholders.
Also, did you see the part in the prospectus where the proceeds of this offering could be used to pay down debt? That may be trade debts the company has incurred as I indicated above or it might be paying off the some of the convertible debt Tony and others bought. If that happens, then you know the end of the road has been reached for shareholders.
I guess what we don't know is how fast they are recruiting patients right now. Perhaps they will have enough by the time they meet with the FDA. By relaxing the MAraviroc requirement and by adding the use of non-approved drugs to the optimized background regimen, they may be able to add patients much faster than in the past. But the more patients they have the more money they need. So, we still await a PR on the fundraising that is either already happening or about to be announced. We need to get that out of the way and now we need to find out what the FDA and company can agree upon regarding their study. I imagine this will not be available on 10/12 as the FDA will likely take the company's feedback and evaluate it before issuing some sort of guidance about the combo trial and maybe mono too, who knows?
The Clinincaltrials.gov site was updated again yesterday. I am not sure what was updated other than the date for the PE and trial completion. Now, it says the PE will be in October and the trial will be completed in April 2018.
The press release today does clear up some of the open questions. I suspect the change in the protocol to exclude Maraviroc and include the use of non-approved drugs (read Ibalizumab and Fostemsavir) in the trial is what has caused the need for the study to remain open and recruiting in order to get a clean data set for the FDA to be able to review for the BLA.
This delay likely means approval does not happen until mid 2019. But there remains uncertainty about what exactly is going on between CYDY and the FDA over PRO 140.
I like the idea that the company said something. They indicated they are "strongly confident" in the commercialization of Rexista. Could that be an indication that they are hopeful to get a tentative approval for Rexista with a abuse deterrent label for IV on 9/25? Or does it mean they expect to get shot down this time and then go back for a second shot at it later? I can't say but we should know before the end of the month.
If they get a tentative approval and then win the court battle, then we really have something and the stock will jump. Of course, Purdue can tell if they are not going to win and would likely settle first.
I like the fact they are strengthening the patents surrounding PODRAS as I think this is where the really big money is.
They did not say anything wonderful about Seroquel and Focalin sales. I think they would have if there was something to talk about on that front.
There was nothing said about cash or the balance sheet. That is all important and an unfortunate omission. They have rising legal costs, rising testing costs and, as best we know, not a lot of cash. Either our new CFO delivers cash from some sale of product rights or some partnership agreement or there would seem to be a high likelihood of some type of new equity being sold.
No one should ever be inclined to trust what he says.
From the infamous ImpactTrader, so we can ignore it.
The Mackie's analyst's forecasts are based on his assumptions. But they are likely more informed assumptions than ours. At the same time analysts forecasts are wrong all the time, so don't bet the farm based on his assumptions. I bolded the 2016 and 2017 annual numbers and the unbolded numbers are quarterly revenues.
Here is his actual table but unfortunately, it does not copy well so you will have to wade through it very carefully to figure out how he has things categorized:
IPCI quarterly income (US$ '000)
Q1 2016A Q2 2016A Q3 2016A Q4 2016A 2016A Q1 2017A Q2 2017A Q3 2017E Q4 2017E 2017E
Revenue
Other Generic sales $0 $0 $0 $0 $0 $0 $0 $4,680 $5,070 $9,750
Share from Par ANDA sales $567 $556 $555 $532 $2,210 $1,160 $1,927 $800 $700 $4,587
Milestones (Licensing) $0 $0 $0 $38 $38 $75 $75 $75 $75 $300
Total revenue $567 $556 $555 $569 $2,247 $1,235 $2,002 $5,555 $5,845 $14,637
What was that other blog?
I 100% agree that it is not clear what is going on right now. I suppose there is a positive slant you can put on the recent developments, as some have done, but that seems like a pretty big stretch to me. I actually think the results will be good, as indicated by most of the patients staying on the drug after the trial is done, but I have to think the company is worried that the FDA will not accept the data as it might not be in line with the original protocol (i.e. - patients who took Maraviroc may have been included halfway through the test in order to find the number of patients needed to complete it in a timely fashion). Now, I can't believe the company would have taken that step without informing the FDA but it also sounds like they did not get a firm FDA sign-off on it either, thus the need for the meeting to resolve how it will all be handled.
But all of that is complete speculation as we don't have enough info to know exactly what has transpired, but we do have enough hints to speculate about what is going on. If things are going along fine and the threat to the phase III combo trial results is not significant or maybe even non-existent, the company should say something to make that clear. Otherwise, your speculation about the results possibly being bad cannot be ignored.
I think that is because the trial is still open and possibly recruiting new patients. CYDY indicated they had 30+ patients but did not say the trial was closed. The recently updated clinicaltrials.gov site indicates they are still recruiting. This might be related to the need to meet with the FDA to discuss data analysis given the changed protocol. With some having taken Maraviroc and some not, they may need to figure out how to analyze the data in a way the FDA would agree with. Or they may need to get a lot more patients now who did take Maraviroc. Or there may be other reasons.
Now Tony's answer to this question should really cause CYDY investor's concern. In Mid0-April TOny is suggesting the BLA would be filed by the end of June and the trial is still apparently recruiting as we speak. How could such a smart guy be so off the mark???
So with the trial not even completed in mid-April, he thinks he can have the BLA filed in June???!!! If so, you should expect a CRL because that is nowhere near the time they would need to do it right. I can't fathom why he would set up such a ridiculous expectation.
I hope I am wrong but you need to give some serious consideration to the idea that you might be stretching to hard to find positives when the negatives are staring you in the face.
If you are not concerned about the line you quoted, I think you should read it again. How is it possible that CYDY does not already know the next steps in analyzing the data. Then, you add the change in the protocol and you only have more questions. In most phase III trials, the gameplan for how to analyze the data is known from the get go and the protocol does not change late in the game. We actually can't be sure when the protocol has changed. It may have been in late August as the trial is still listed as recruiting. If you don't have a lot of questions about all of this and you think this is normal, you need to think a little harder about it.
Mackie's Q3 Sales number is $5.55 million with what appears to be $800,000 coming from Focalin and $4.65 million from Seroquel. So, it is possible the Mackie analyst has a better read on where sales are going or that he will be revising lower. Hard to know for sure. But I am sure the analyst has access to the Bloomberg data.
I would argue that you and Misiu are working way to hard to ignore some serious red flags. It is all a matter of perspective.
Drug companies have meetings with the FDA all the time but we rarely hear about them. When the company puts out a PR about a meeting, however, then that must be driven by their lawyers and it is telling us something. It is possible it is good news and I hope it is. My instincts tell me to be wary.
Yes, as that would indicate that everything is going along as normal and we will have our PE results shortly and the BLA application should proceed as normal sometime in the late Spring/ early Summer of 2018. The fact the company had to send out a PR about meeting with the company indicates there is something going on that is not normal. It may be something positive is happening, but I think there might have been more hints about that in their PR's if it were the case. When we see now that the trial protocol has been changed, that only raises more questions. None of which have any clear answers. So, I would definitely be happier about PRO 140 if its test were simply proceeding in a normal fashion without the need for consultations with the FDA about how to analyze the data. That is a big red flag.
Are you trying to tell me that you really have no concerns about how all this has developed? Clearly, we do not know what is actually going on and there certainly is a risk that something might be amiss. Since the combo trial is apparently critical to the future of CYDY, there has to be some concern as long as the company has not shed any light on what is going on.
You would think that would be the case but then why do they now need to go to the FDA again to discuss it all? It would be nice if someone with access to management could get a read on what exactly is going on here. Better yet, it would be nice if the company could put out a PR explaining it all.
Here is the latest weekly report on Seroquel sales. There are updates every Friday. The growth continues in total prescriptions. The various letters refer to different types of insurance coverage. X is Medicare, T is private insurers, G and M are Medicaid.
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Count By Payment Type By Week
MALLINCKRODT P...
Payment Type 08/25/2017 08/18/2017 08/11/2017 08/04/2017 07/28/2017 07/21/201
Total 443.00 384.00 332.00 221.00 175.00 183.0
X 150.00 147.00 115.00 74.00 49.00 69.0
T 111.00 116.00 93.00 68.00 47.00 57.0
G 91.00 66.00 65.00 48.00 48.00 29.0
M 75.00 45.00 47.00 27.00 23.00 20.0
C 12.00 8.00 8.00 4.00 4.00 8.0
A 4.00 2.00 4.00 4.00
Source: Symphony Health Solutions
From Mackie's report on the new CFO - it will be interesting to see how he raises cash, new shares are not to only possibility.
Mr. Patient’s experience with Merus should be beneficial to IPCI. We believe his first priorities will be to strengthen the balance sheet and
try to rebuild investor confidence.
Rexista-Oxycodone PDUFA date: On July 26, the FDA advisory committee meeting set the tone for this product and voted in favour of not approving the formulation with its current clinical package. The PDUFA data for IPCI’s Rexista-oxycodone is September 25, 2017 – we are expecting a complete response letter, that is, we do not expect approval at this time. IPCI needs to get out from the shadow of Rexista and refocus its pipeline.
IMPACT – Maintaining HOLD and Target Price We expect IPCI to trade at a discount to its peer Canadian specialty pharmas due to: its current revenues mix being derived from generics (not brand), lack of near term new
product launch visibility, and potential
If you were a new CFO coming into this situation, my guess is you would tell Odidi that you would accept the job under the following conditions and than list off five or so requirements. At the top of that list likely would be getting a capital buffer so you are not always in a cash bind. Now, the PR does say he likes to operate in a low cost way. So maybe he is happy not to have a capital buffer and is up to the challenge. But the risk to us shareholders is that he throws us under the bus as he likely cares more about the future and his legacy and does not even know us. Of course, Odidi does not want to be diluted much and they really don't need a ton of money. But with the stock price so low, even a small capital raise is pretty dilutive.
The change may have occurred some time ago. There does not seem to be any rules in place about how timely you need to be in updating the Clinicaltrials.gov website. That or the rules in place give you a lot of time to update it with new info.
Ibalizumab is likely to be approved in November if delays can be avoided. It is administered by IV every two weeks and will be the first long acting HIV drug on the market.
PRO 140 could be the second one but it is still more than a year away from approval.
I have not focused on others but know there are several in the testing phase. I don't think any has advanced to phase III yet but that is not based on an exhaustive review of the landscape, just what I believe I read somewhere in the last months.
The ones that are being studied are mostly once a month drugs. The second version of Ibalizumab, which has a long way to go before getting on the market, is targeting a once a month injection.
Very interesting. Did they just go ahead and make that change themselves so they could actually fill up the trial? Or did the FDA agree to it. Is this why they need to talk to the FDA about how they are going to analyze the data? It was kind of ridiculous for the Maraviroc requirement to be there in the first place and I would think the FDA should be able to see that.
Also, they took away the requirement for there to be one fully active approved drug and just made it one fully active drug which likely means they can use Ibalizumab and Fostemsavir if the patient is resistant to all the standard HIV drugs.
It will be interesting to find out what exactly happened here. Di they go to the FDA and request these changes or did they decide to make them and ask for forgiveness later. The changes make sense so the FDA should agree. But it also will complicate the data analysis since some patients will have been in the test under the original set of conditions and some under the latter set of conditions.
It also may be why the test has not been officially closed yet. The FDA may want them to recruit 30 patients under the new set of conditions. SO this announcement likely explains a lot about the weirdness of the last 2 PR's.
I think the best you can hope for is they give PRO 140 the BTD and only require one phase III test for mono. There is no way the current phase III for mono will be cut short. PRO 140 might be good but it is not that good. This would only happen if there were not other therapies available for HIV patients but there are actually many. PRO 140 in mono will be quite a departure for the HIV community which is sold out to using three therapies. In most patients, those three therapies are working and there will be a reluctance to stop using something that is working as you can't really go back to an HIV medicine once you stop using it. Even if the patient wants to use PRO 140, their doctor will be initially reluctant to allow it. Since nobody will die if they don't rush PRO 140 to market, it will not be rushed.
This is a look at total number of prescriptions by type of Seroquel. As you can see, ER/XR versions are still in the minority.
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Count By Drug Name By Month
Drug Name 07/31/2017 06/30/2017 05/31/2017 04/30/2017 03/31/2017
Total 1.30M 1.33M 1.36M 1.26M 1.39M
QUETIAPINE FUMARATE 1.18M 1.21M 1.24M 1.14M 1.25M
QUETIAPINE FUMARATE ER 82.04k 79.06k 75.17k 68.67k 74.73k
SEROQUEL XR 35.25k 40.86k 47.45k 47.40k 55.18k
SEROQUEL 4.50k 4.68k 4.89k 4.61k 5.27k
Source: Symphony Health Solutions
It can come at any time but the FDA usually drags things out rather than speed them up. And if they decide to CRL Rexista, it should be a matter that gets heavily debated within the FDA before being implemented as it really should get tentative approval based on the facts. Furthermore, it sure seemed to be what the FDA believed as well based on the ADCO briefing materials. If it gets CRL'ed, it is only because the bad optics of approving an opioid that an ADCOM reacted very negatively to get in the way of the truth. Unfortunately, that is a real possibility. Hopefully there are many in the FDA with courage and common sense and Rexista gets tentative approval for IV. Literally, some people will likely lose their lives if the FDA does not approve it.
Unfortunately, you really need to add the possibility of a CRL for Rexista to your list. I hope it doesn't happen but the main analysts covering the stock, who is no fool, is suggesting that si the likely outcome.
I spent some time pondering the whole combo/mono market thing and will share some thoughts to get some good feedback.
First, while the company has a chart indicating a $5 billion potential market size for combo (assuming all 207,000 estimated patients paid the estimated price of $24,000 annually for PRO 140), they don't really emphasize it much and their own focus is on mono. And we all seem to agree that the focus should be on mono. And they can't seem to attract decent financing - another clue that combo, despite having reached the primary endpoint of its first, and hopefully only, phase III trial, is just not setting anyone's heart a'flutter. My guess is everyone is assuming it will be hard for them to find marketing traction in combo despite the theoretical $5 billion market size. If you still have to take pills, why also take a weekly shot? Only those who are struggling on one of the classic HIV meds would potentially try it and they may be more likely to give a standard med in one of the other classes a try first. The marketing story for mono is much better - just take one weekly shot and be done with the daily pills and any related side-effects.
Second, there is no way the market for combo is 207,000 patients so they should get the ODD from the FDA. First, you can pretty much eliminate almost all of the 20-25,000 patients that are MDR as few of those will take PRO 140 and those patients must be assumed to be part of the 207,000. Second, no one really knows (I have not seen any data at least) how many patients who have two working classes of the five available are struggling with a third, but I am sure it is far less than 207,000. And many of those will likely first turn to one of the other two standard classes of HIV drugs before trying PRO 140 (simply because this is what doctors have always done in this situation and it will be hard and take time to convince them to do otherwise). Clearly, there are some patients who fit the mold but it may be measured in thousands rather than hundreds of thousands. Still, combo could find a nice revenue stream from them. Let's assume for arguments sake they can find 5,000 patients out of this group - that translates into $120 million of revenue at a $24,000 annual treatment cost for PRO 140. There is nothing wrong with that. It certainly warrants seeking approval for combo as we wait for mono.
Additionally, if for some reason mono does not get approval, you will at least not go belly up and you will have the funds to pursue other indications.
So, while I remain perplexed about the company not talking more enthusiastically about the combo market and its inability to get more traditional financing for the company's clear financial needs and given its interesting prospects, I am more encouraged about the company than I was previously when it seemed mono was all they had and that it may be some ways away from approval yet.
I am also still not clear at all about what is going on with the meeting with the FDA. It could be something very positive or something very negative and I wish the company would at least drop a few hints if it is something that has positive implications. In the absence of that, history suggests assuming the negative is the wise decision.
Financing/dilution is still a big hurdle for me. I think it is very weird for the company to be raising money right now in what appears to be a secretive fashion. I still find it odd that Tony and his crew gave themselves convertible debt but only sell equity and warrants to others. I need to hear the PE data, what the outcome of the FDA meeting is and what the company's financing plan is. The stock will be much higher if all that comes out in a positive fashion but it should still have plenty of upside left in it. If any of that comes out with a negative bias, the stock will get hit hard.
If I recall correctly, did not the terms of the deal with MNK also include payments that might amount to $1 million per month for perhaps 10 months or so to help cover the costs of developing the drug?
Here may be a simpler way to look at it - this is almost all the sellers of Seroquel XR generic by monthly revenues. There are several more below MNK but they did not fit on the screen.
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Dollars By Manufacturer By Month
Manufacturer 07/31/2017 06/30/2017 05/31/2017 04/30/2017 03/31/2017 02/28/2017
Total 602.15M 614.33M 629.12M 586.80M 639.82M 560.06M
ACCORD HEALTHCA 178.56M 175.31M 172.02M 166.76M 185.40M 164.97M
LUPIN PHARMA 101.62M 96.77M 100.71M 97.98M 100.56M 90.19M
TEVA USA 65.56M 66.28M 67.36M 60.10M 65.27M 52.02M
ASCEND LABS 48.47M 47.32M 42.84M 34.36M 28.29M 17.00M
NORTHSTAR RX LL 46.30M 50.22M 55.22M 49.35M 52.39M 42.00M
ASTRAZENECA 39.52M 42.82M 44.67M 41.43M 48.02M 43.85M
APOTEX CORP 31.18M 38.20M 38.54M 34.04M 36.71M 32.30M
PAR PHARMA 21.49M 26.67M 34.99M 35.18M 38.03M 32.92M
BLUEPOINT LABS 19.92M 20.68M 21.23M 19.23M 23.35M 21.81M
SUN PHARMA GLOB 15.48M 23.64M 27.13M 24.05M 26.44M 22.48M
MACLEODS PHARMA 12.51M 2.88M 1.37M 325.63k 46.98k 6.10k
WEST-WAR/ROXAN 7.79M 9.70M 12.87M 16.19M 26.27M 30.64M
TRUPHARMA, LLC. 7.58M 6.16M 1.65M
DR.REDDY'S LAB 2.34M 3.07M 4.15M 4.18M 4.56M 3.88M
UNICHEM PHARMA 1.52M 1.92M 1.62M 1.38M 1.93M 3.61M
SANDOZ INC 1.39M 1.63M 1.84M 1.75M 2.11M 2.05M
MALLINCKRODT PH 412.51k 138.47k
MAJOR PHARMA 185.83k 363.66k 461.73k 261.91k 134.17k 54.23k
Source: Symphony Health Solutions
Sorry - those were total prescriptions not revenues - let me try again. Obviously, those two companies were selling it before June as well.
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
LUPIN PHARMA
Strength 07/31/2017 06/30/2017 05/31/2017 04/30/2017 03/31/2017 02/28/2017
Total 224.59k 215.09k 224.82k 217.48k 225.89k 203.14k
100MG 53.82k 51.75k 53.63k 52.16k 54.17k 48.90k
50MG 47.57k 45.41k 48.01k 45.94k 47.75k 42.75k
25MG 47.01k 45.12k 47.07k 45.59k 47.72k 42.89k
200MG 29.70k 28.43k 29.73k 28.87k 30.10k 26.84k
300MG 26.84k 25.73k 26.45k 25.82k 26.84k 24.21k
400MG 19.65k 18.65k 19.92k 19.10k 19.31k 17.55k
Source: Symphony Health Solutions
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Count By Strength By Month
ACCORD HEALTHCA
Strength 07/31/2017 06/30/2017 05/31/2017 04/30/2017 03/31/2017 02/28/2017
Total 394.07k 396.47k 390.98k 373.51k 415.64k 364.16k
100MG 85.90k 95.02k 94.15k 92.65k 102.79k 86.44k
25MG 85.13k 88.41k 88.89k 81.68k 91.35k 78.43k
50MG 75.83k 77.90k 74.77k 70.15k 73.13k 62.79k
200MG 51.99k 51.43k 49.25k 43.40k 51.08k 47.97k
300MG 50.90k 42.39k 43.18k 45.18k 52.68k 45.51k
400MG 41.21k 39.90k 40.74k 40.46k 44.61k 43.01k
150MG 3.12k 1.42k 3.00
Source: Symphony Health Solutions
Thanks! I have seen that above before but that version gave a little more info in the footnotes. Do you know how they define "second line therapy"? I assume a patient on any of the normal 5 classes of drugs is on a first line therapy but perhaps that is not the correct way of thinking about it. I have not been to one of the company's presentations, but have listened into many of Nadar's conference calls and never got the impression they were focusing much on the combo market. But if it is truly a 207,000 patient market they should be making a lot of noise about it. It certainly would help them raise the needed funds. And it makes it all the more difficult to understand why they continue to try to raise money via Paulsen versus one of the larger brokers. IF this is a legit market and they have completed enrollment of their phase III trial with results coming shortly, they should be able to convince a normal investment bank to work with them.
I agree, that sentence could open the door for PRO 140 to a wider group of patients and it fits nicely with the idea that the FDA would not give the drug ODD. So, perhaps PRO 140 will have a legit market for combo that would make up those patients that are resistant to two classes but not three. Also, there are likely a higher percentage of CCR5 patients in the two but not three category. Has the company ever tried to quantify that market size? I have not seen it anywhere and I have always found that to be strange.
I suspect a lot hangs on the word "intolerance". Cross resistance is pretty straightforward (and I am not sure how much of that there is) but what exactly does intolerance mean? Misiu suggested it means side-effects. If so, all the HAART drugs have side effects, so that could be pretty broad. If intolerance means taking the third drug makes you very sick, then the market may be smaller. But either way, this is clearly the opportunity for combo and it may be significant enough to make some serious money from.
What I don't get is if the company needs to raise money, why is it not putting that up in lights to help them do so? Why don't they talk about it as often as they can? That doesn't make any sense either. So, is there still apiece to this puzzle that is missing?
If the 2 but not 3 resistance market is where PRO 140 will get most of it sales, the competition we need to keep an eye on is Fostemsavir. Fortunately, ViiV has seemingly sidelined development of this drug and now has its phase III trial ending in early 2020. Fostemsavir has the BTD but something must have gone wrong with the test as they have really put the breaks on. So PRO 140 should have plenty of time to exploit the 2 but not 3 market before any competition arrives.
You did not understand what I was saying and that is likely because I did not lay it out as clearly as I should have. I believe the FDA almost always provides a label that closely mimics the phase III tests. So, I think the for PRO 140 in combo will be for just what it says on clinicaltrials.gov. In practicality, however, since Ibalizumab will have taken almost all those MDR patients by the time PRO 140 is approved, PRO 140 may well only have as a market those patients who need yet another drug because they are also resistant to 4 or 5 classes. Thus, those patients would use both Ibalizumab and PRO 140 in combination with one other classic HIV drug if they are 4 class resistant or just those two if they are 5 class resistant. Does that make it clearer?
We investors almost always assume sales will ramp up faster than they do for a new drug. So, sales could be looking pretty good by the time we get tot he fourth quarter or the first quarter of next year, but I think the chance for a negative surprise in 3Q17 is high.