Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
And that is not a good thing. I have found the Symphony numbers to be off the mark in other situations but I would not expect them to be off the mark by as much as is suggested by the analysts forecasts. Which means those forecasts will be coming down.
Here is a look at it broken down by strength:
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Dollars By Strength By Month
MALLINCKRODT P...
Strength 07/31/2017 06/30/2017
Total 412.51k 138.47k
400MG 152.54k 34.08k
300MG 105.42k 45.51k
150MG 60.77k 22.92k
200MG 51.36k 17.91k
50MG 42.43k 18.04k
Source: Symphony Health Solutions
Unfortunately, yes. But I want to emphasize that the data as reported by the company who collects it might be off and also that my compiling it from the way it is presented could also have been off. Here are the numbers for the two months:
Bloomberg Intelligence: Molecule Detail
Molecule QUETIAPINE FUMARATE (RX_06147 Comdty)
View TRX Dollars
MALLINCKRODT P...
Payment Type 07/31/2017 06/30/2017
Total 412,510 138,470
Source: Symphony Health Solutions
I hope I proved your point about the MDR market being a small one as that is what I have been saying all along. So we are and always have been in agreement on that point.
The PRO 140 combo trial is very similar to the Ibalizumab trial is focused on MDR patients. Therefore, one would expect the label for combo, if it gets approved, will be for MDR patients. And there will not be many patients for PRO 140 to serve in that market. If the drug is priced at a high price, it could still be a decent little revenue generator for CYDY but nothing to get much excited about. But even those revenues would need to be shared with a marketing partner and it will be hard to find one given how tiny the market will be.
Frankly, I have no idea what exactly the overall strategy in HIV is for PRO 140 but I am willing for the company or someone to explain it to me. You suggested they are doing the combo at the FDA's behest because the FDA wanted to check out PRO 140's effectiveness in combo prior to going mono, but the mono trial was started a long time ago so I am not seeing how that paves the way for mono. The combo trial seems largely meaningless to me at this point. The mono trial is where CYDY should be spending its efforts, particularly if it wants to get bought out. Has the company ever talked about what the marketing strategy for combo would be? How does the combo trial fit into the overall strategic plan for CYDY? It is costing them quite a bit of money but I am not sure what is going on with it and now they are going to the FDA to talk about it further. So they must be trying to convince the FDA of something that would give the combo trial some longer term commercial meaning. If so, I have to imagine that would entail another phase III for combo that would target healthier patients.
Usually, you can figure what a drug's pathway is from the clinic to being commercialized. I can easily see one for mono but not for combo. But perhaps the FDA will be receptive to whatever the company wants to discuss about the combo in the upcoming meeting and everything will become clearer.
The Bloomberg data is sketchy and it is not easy to manipulate either. There are all different types of ways of defining sales as well. But it looks to me like sales have been around $500,000 through June and July of MNK's Seroquel XR.
There is no link as the sales info is not on the internet but on Bloomberg's system.
That came out the evening of the ADCOM and I doubt the FDA gave them any authoritative feedback right away. One has to think they have had more substantive discussions with the FDA since then. If the FDA relies on the evidence, they will give it a tentative approval for IV and the briefing document seemed to indicate that is what they were shooting for. I am worried the reality might not sync up well with the facts, however. My principal reason for that concern is the Mackie report's saying they would likely get a CRL and would need to refocus on their other drugs. I have to assume he spoke with the company and got some sense of where things are at. I also assume he would like to get a piece of any offering they might do and that he needed to communicate to IPCI investors where things were actually at ahead of any share sale. I could be completely wrong about that but that si my best guess at the moment.
Mallinkrodt's Seroquel sales, specifically, do not look that good on the service that does a sketchy job sometimes of tracking such sales on a weekly basis. It may prove to be bad info but I would rather the numbers look good.
Just to be clear, I said the next generation of Ibalizumab. Ibalizumab is TMB 355 and the next generation is TMB 365. As I said, TMB 365 is a long way away from being approved. PRO 140 for mono should be on the market well before TMB 365 sees the light of day.
I do not believe the company has made any public statements about the label they will be pursuing for TMB 365 yet, but it is not hard to figure it out. They will already have the MDR market locked up with Ibalizumab, so it would make sense to go after the larger market with the new and improved version.
No, I am still a sizable investor. And I am therefore hoping they don't shelve Rexista. The only way I see them doing that is if the FDA gives them no path forward, which is a realistic possibility that you should contemplate a little more.
The good news is that even if they do have to shelve Rexista, they have plenty else to work on which could add a tremendous amount of value. I don't own it for the generics, so I tend to discount them (but I like the revenue they can bring in these lean times - hopes its enough). I believe you can justify owning IPCI on PODRA alone. I am not sure why Regbatin has not been partnered yet but that is not inspiring confidence. However, if that too starts moving forward, it would be exciting and also would be enough to justify holding onto my shares.
I am looking for a game plan being laid out to me by the company and an offering that would allow me to average down at an attractive price. I would not mind seeing more professional management as well. A lot could happen in the next month or so. I don't think all of it has to be bad but for myself, I am assuming Rexista is given a CRL by the FDA and that the company refocuses on PODRAS and Regbatin. If I am wrong, and I should be wrong if the facts win the day (unfortunately, they don't always do so as we saw at the ADCOM), all the better. But I am not counting on it.
Yes. The next version of it will be a once a month shot that will likely target the mono market. IT is already in testing and is supposed to be longer lasting (thus the one per month shot) and have greater efficacy. But it is still a long way away from hitting the market.
TaiMed focused on the MDR small market with Ibalizumab because they were once a poor company like CYDY and needed to get a product on the market as fast as possible to survive. The MDR market was the fastest way to get to sales and earnings. If they had more money, they almost certainly would have targeted Ibalizumab as a first line therapy.
IPCI would only shelve it if the FDA shelved it. But if the FDA shelves it, IPCI does not have much choice. They can continue to pursue it and put forward another application and start the whole process all over again, but that would take time and money and they don't have a lot of either right now.
IPCI would only shelve it if the FDA shelved it. But if the FDA shelves it, IPCI does not have much choice. They can continue to pursue it and put forward another application and start the whole process all over again, but that would take time and money and they don't have a lot of either right now.
I have not placed a valuation on CYDY but i know that $4-$6 billion is ridiculously too high. On TH, I think it should be selling at 2-3 times its current price right now. But it helps to remember that Ibalizumab has long ago successfully completed it phase III test, is now 2-3 months away from being approved, has the Breakthrough Therapy Designation, the Orphan Drug Designation and has Priority Review - CYDY has none of those attributes. TH has also outlined exactly what its market is and how it will be selling into that market. It is a company with more than 80 employees and an already approved drug that is generating about $40 million in sales this year. Of those 80 employees, about half make up the sales team for the company - CYDY has no marketing effort. TH also has a strong balance sheet and is looking to acquire a third drug.
The two companies are very different and are at two very different points in their life cycle. TH deserves a nice valuation but I am not suggesting it should be anywhere near $4-$6 billion. $1 billion to $1.5 billion is more appropriate. So, in light of all that, I think you might be able to understand why I am worried you are leading yourself and possibly others far astray from reality with your $4-$6 billion estimate for CYDY.
No, I really don't think so. They would just leave it in place and never use it. If they withdraw, it means something is going to replace it. I would not get your hopes too high that the generic's revenue is going to save the day this quarter. I was looking at a service on Bloomberg that estimates drug sales and I did not see anything there which would give me great comfort regarding Seroquel sales. Those estimates have been wrong in the past, but it is all we have to go on at the moment.
Like you, I expect very good test results but I would not translate that into a valuation anywhere near as high as you have suggested. When it comes to valuations, you are just far off the mark. One day CYDY might be worth that but it would be several years from now. No big pharma company is going to buy the company for anything close to that anytime soon. It is just irresponsible to suggest such a high number and it risks costing some people a lot of money. You may genuinely believe that number is a good one but I would urge you to try to do the math and some simple probability analysis before using such a high number and perhaps leading someone to speculate way too much of their money on CYDY.
It is being withdrawn most likely because it is going to be replaced with another prospectus for another offering. So, I doubt it is good news. It is either neutral news as they needed to update the shelf prospectus for new info or they are about to launch an offering. Given that Mackie took their sell rating off the stock, my guess is they might be part of a new offering soon but they were justified in taking the sell rating off due to the price being below their target price of $1.
If I am right about an upcoming offering, that is when you would want to average down. It may well be also effectively an admission by the company that the Rexista application is DOA and they need to move on. That might be hard to hear and it certainly does not seem fair at all, but it may be the reality. I hope I am wrong but don't be surprised if the company announces something to that effect soon.
Alternatively, it could be an announcement that they are raising money to do the HAP tests required by the FDA and Rexista is still very much alive. That would be more sensible given that Rexista would be the best ADF opioid available, but my faith in the FDA is not high in this matter.
No one knows the future but I can say with about 99% certainty that there is no way anyone should believe that CYDY is worth $4-$6 billion. There is simply no justification for saying something that crazy right now and you risk deluding innocent people when you say such things.
The premise of the Mackie note was the company has to move on to a new development pathway since Rexista is almost certainly going to get a CRL. I don't know if that is just the analyst's opinion or if he was told as much by the company.
So, it is probably best to assume a CRL and that Rexista is thrown on the ash heap, never to be heard from again. To me PODRAS is the easiest way forward and the most likely to attract a partner to IPCI pretty quickly as well. If they can get the next round of tests done (human testing) and it shows promise, there is hope. The question will be if the generics can keep the company afloat from a cash flow perspective or will we need an equity raise first. My guess is the ATM will continue to be used as the monetary need may not be all that high. The PODRAS tests are probably pretty short and cheap. Also, if Rexista is dead, then there are no more lawyers needed
to fight Purdue and maybe some other meaningful cost reductions can be implemented as well.
All that being said, there might not be any good news coming from the company until 2018.
Many on this board have made claims about a buyout that have seemed pretty excessive with regard to the possible price. One never knows what is going on behind the scenes, but if I were one of you who thinks you are going to get paid a lot on a buyout anytime soon, I would do my best to curb my enthusiasm. CYDY does not exactly have a strong hand in negotiations at this point. That might change once mono phase III results are available but it is hard to see it right now. Also, with no cash and hardly any staff, CYDY would be negotiating from a place of weakness. KITE is a real company in every respect and that is what commands a huge buyout price.
BTD usually are given much earlier in the drug testing process. Has any other drug been given BTD after its first phase III was nearly completed?
I think you are also forgetting that the current phase III trial will not actually be completed until February 2018, then you need time to put the application together. Early 2019 is the best hope for approval but investors should be aware there are almost always delays in the FDA approval process.
Also, how can the company be actively raising $15 million in new money without a filing about it? Is it covered by some other previous shelf filing? Shouldn't we at least have a press release on that. And if they couldn't raise $15 million with a more attractive convertible offering, how are they going to raise it with a less attractive stock/warrant offering?
I think having Tony at the helm right now is absolutely critical to the company navigating the significant hurdles the company still faces but there has to be some way to translate good test results into a marketable product. It is going to be interesting to see how this all works out, but it will likely work out. The only question is the dilution required to get to there.
Remember, there likely are not a lot of revenues associated with combo commercialization and mono is still a ways off., especially of a large second phase III is required by the FDA as I would expect. Has the company ever explained how they see the market for combo in any of their presentations? If so, can you point me to that?
Mackie raised their rating on IPCI to a Hold from Sell based on price versus their $1 price target. They expect a CRL on Rexista.
It says 9AM Eastern on the website but 9AM Pacific on the proxy statement. So, the eastern on the website is a mistake.
It is tomorrow at 9AM Eastern time. There could be a PR before the meeting.
That does seem extreme but let's try to work out what approval might occur for combo. First, the trial needs to end, which should happen in mid-February. Then they need to compile the data - I would guess that takes you to late March. Then they need to complete and file the NDA. It took Taimed a good 6 months to do that so let's use that as our guide - so we are now at late September 2018. Now, if PRO 140 gets no special treatment from the FDA, it will take at least 10 months for the FDA, to approve it, so we are now in July 2019. If it is sped up by the FDA, maybe it gets approved by March 2019.
Where did you get the idea I thought IM was easier than SC? I don't think that. But I do suspect the TaiMed purposefully chose to go the IM route in order to cut the physician in on the deal and thereby give him an incentive to prescribe Ibalizumab. They have tested both IM and SC and apparently will go the IM route.
My sense is that Theratechnologies plans to pick up the cost of the home infusion if not covered by insurance, but i am not certain of that.
PRO 140 is not going to quickly become a first line agent, even if it should. It is just not the way these things develop.It takes time and a lot of testing. I believe CYDY will be asked to do a second large mono trial if the first one produces good results, as it likely will.
Patients can't afford to pay for Ibalizumab but the insurance companies will cover it.
Misiu is right - I will remind you that it will be very convenient to get your IV of Ibalizumab. The company is setting up a program where the IV will come to you at home, at work or at the coffee shop, if necessary. So your dire scenario is off the mark. But it is really off the mark because by the time PRO 140 gets on the market, Ibalizumab will be an injection rather than an IV itself as they expect to have a label extension about 1 year after Ibalizumab's approval for an injection version. Now, it will be an intramuscular (IM) injection versus PRO 140's subcutaneous (SC), so you will still need a nurse to administer it. But it will only be once every two weeks compared to once a week for PRO 140. And the key thing that goes in Ibalizumab's favor here is the doctor's get paid for administering the Ibalizumab IM shot but not for PRO 140's SC shot. I don't want to be overly cynical, but which do you think the doctor might prescribe first? Also, the doctor will be happy to not have to order a tropism test with Ibalizumab, but they would before they could use PRO 140. Doctors would soon learn that most MMDR patients are CCR4 not CCR5 and thus doing this test would show the patient is ineligible for PRO 140 most of the time.
PRO 140 is a great drug but in MDR, it does not have much of a chance versus Ibalizumab.
We are actually all on the same team - the one that wants their investments to return them a nice profit. Talking about the pluses and minuses of all the investment opportunities really helps narrow down the mistakes, although some are always inevitable. But these boards are a great source for learning things you did not previously know or consider appropriately as I think has been shown by the dialogue here among many posters in recent days. I certainly have benefitted from the accumulated knowledge.
What you suggest makes complete sense to us commoners. But the FDA just has a different way of looking at things so I don't think the path for PRO 140 would go as smoothly as it should from 3 class resistance to 2 or 1 class resistance on the label.
In Rexista's case I have a hard time blaming the FDA as it was more the ADCOM members who lost their way during the proceedings.
A label expansion typically requires some additional testing, even if not a full blown phase III. That takes time and money. My guess is the company focuses on mono rather than trying for a label expansion on combo. IF the goal is to sell the company to Gilead or Viiv, mono is the way to go as that represents the biggest threat to their current HIV franchises.
You said you were bullish on combo
The phase III combo trial is a multidrug resistance (MDR) trial. But Ibalizumab is a better drug than PRO 140 for this market (covers both tropisms where PRO 140 only covers one and the patient needs to take a test to show they have the CCR5 version before being able to take PRO 140) and it will reach the market well before PRO 140 does. Only about 20-30% of MDR or salvage patients have the CCR5 version of HIV. What exactly will be the market for PRO 140 if it gets an approval based on the combo trial? The label will by necessity be for salvage patients given the trial design but that market is quite small 6,000 - 7,000 patients and Ibalizumab will likely have captured most of those patients before PRO 140 gets approved. So, what is the market for PRO 140? Who would even market the drug for them to such a small market. Certainly not Gilead or Viiv.
Can you give me some insight as to why you think PRO 140 has a market waiting for it to serve? How are they going to translate the combo approval into revenues given the labeling restriction and the fact the market is not only small but will already be being served by another, better drug?
Mono is where CYDY will make its money in my opinion.
Given the claim in today's PR that 11 patients out of a likely 11-13 or so had no detectable viral load after 25 weeks of therapy, the chances of the PE being outstanding seem pretty high. I suspect the PE info will be released as quickly as they can and may be well before the 10/17 meeting with the FDA. And there will be an offering immediately following that.
The big question is how big an offering will it be? I don't have a good answer for that and could see it being in the $15 million range to much larger (a scenario where they throw the old shareholders under the bus in order to once and for all get the balance sheet squared away so they can stop the constant fund raisings that have become so toxic to the share price).
I suppose the PE data could not be outstanding and the 25 week data great and that could add a whole new dimension of weird to the story. If they try to raise money before the PE data is available, then I might believe this as a possibility.
Can someone tell me what the procedure for the trial is again? When the drug or the placebo is given on day one, the patient already on a failing regimen - correct? So, the benefit from PRO 140 should be quite obvious at 7 days as well as at 25 weeks.
I actually agree with significant portions of what you say but I am puzzled why we then have a company which is currently out of money? Should it not have been easy for the company to raise all the money it needed if what you said is true? How is it that a company with such potential has struggled to raise money?
I suspect the former CEO did not inspire a lot of confidence and that is a big part of it. But the drug clearly works well and that should have still won the day. With the new CEO, raising the needed money from normal sources should be a bit easier but the legacy of millions upon millions of warrants outstanding probably is keeping the investors who would normally chase this type of opportunity away.
Many other companies with far less exciting prospects have raised far more money at better prices than CYDY. It is a very strange thing.
They may well have that meeting and report phenomenal results from it. But they also have no money left. They have to find a way to pay the bills and you can easily do the math on their burn rate and the cash they have. I believe they had $1.8 million in cash as of 5/31, they raised about $6 million subsequent to that and their burn rate was $7.8 million in the previous quarter. So, right about now, they are running out of cash.
If there is indeed a chance for very good news coming from the 10/17 meeting with the FDA, they need to raise an additional $5 million or so to make it that far with the hope of raising much more after that at higher, less dilutive prices.
I am sure the reason they noted 11 had no viral load after completing the 25 week course of treatment was included because they need something positive to raise that $5 million on. In fact, I am not sure what the whole issue with the number of patients was but they may have been forced to declare the trial closed so they could release that info to help prepare for the next cash raise.
Not so fast my friend - we need to get some clarity on financing first. That has been my main issue from the beginning. I also am still befuddled by this need for a meeting with the FDA. Now, perhaps in a few weeks, well before 10/17, we will also get the primary endpoint data. Or maybe at the annual meeting there will be some clarity about the discussions with the FDA. But this has always seemed to me to be a good drug, bad company situation as reflected by the sub-par management under Nadar and the never-ending financings/huge potential dilution from already outstanding warrants.
But if you had to choose between a good drug/bad company and a bad drug/good company, you should take the former all the time. What i am looking for is some sign this is transitioning from a good drug, bad company to a good drug, good company. That can really only happen after the balance sheet is fixed.
Also, there is a significant risk in a good drug, bad company situation that old shareholders get thrown under the bus to fix the balance sheet to make the transition to the good drug, good company.
I am with Misiu on this. It sounds to me they are saying that 11 out of 12 or 13 had undetectable viral loads after the full 25 weeks of treatment. WHich are results that are better than I would have expected and I was expecting good results. They are not offering any info on those that have not completed the full 25 weeks yet.