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It is not exactly the wording you would want as it basically says resistance to three or anything that looks like resistance to three, but it does open the door to a better label. Hopefully, the FDA will walk through that door.
Do you have a link confirming that. I thought someone posted here recently that this request had been turned down by the FDA - there was a quote for one of Nadar's update conference calls suggesting that. If you are right, that is very good news for CYDY as it will give them a combo market in which they will have a chance of serving a serious number of patients.
I agree with your thoughts and think the FDA should consider allowing a broader label for both Ibalizumab and PRO 140. I was surprised they did not adjust the terms of the CYDY combo trial protocol to allow that when it was requested. So there must be a good medical reason that we don't understand yet that caused the FDA to force CYDY to stick with the triple class resistance instead of going for just double or even single.
I really don't think TaiMed is competition for PRO 140. TaiMed is going to have the MDR market almost exclusively to itself for several years at least. If PRO 140 and Ibalizumab are ever related, it would likely be for those patients who have become resistant to everything and both drugs would be used together.
PRO 140 will not be a factor in the MDR market which their combo therapy study seems to be targeting. First, PRO 140 only works on the C5 version of the disease and only 20-30%, at best, of the MDR patients are C5. Ibalizumab works on both major HIV tropisms (C4 and C5). Moreover, Mariviroc is already on the market and it works only on C5, so that is really more PRO 140's competition. It is also why it has been so hard to fill the combo trial up since doctors have MDR patients with the C5 tropism already on Mariviroc and the protocol for the combo trial says the patients could not have already used Mariviroc - so it has been very difficult to identify such patients. Furthermore, Ibalizumab will soak up the majority of the MDR patients before PRO 140 even reaches the market. Now, there will always be some patients for PRO 140, laggards and those for whom Ibalizumab does not work are candidates, but that will probably be too small of a number of patients for PRO 140 to be able to recruit a marketing partner for MDR. So, the combo trial's value is primarily to get the data for a Breakthrough Therapy Designation which will help CYDY raise the needed funds for the mono trial, where they really do have a lot of potential, partly because a much higher percentage of the non-MDR HIV market has the C5 version of the disease.
Ibalizumab, or more likely its next version, may one day be competition for PRO 140 outside the MDR market, but that is years away.
IV administration is easy for almost everyone as you well know. If it were not, there would be a lot more people dying in our hospitals. It is certainly more of a hassle than SC, but if you have MDR, it is the least of your worries. Also, Ibalizumab will likely be available via IM injection about a year after it launches in IV form.
You are right that the combo therapy results are the only important thing right now. And there is no reason to believe they will not be good enough.That should allow the company to raise additional funds and keep the ship afloat until the mono results are available. And if those are good, that is huge. And I see no reason why they would not be good. So CYDY has an interesting future, but it is in the mono market, not the MDR market.
The 10-K highlights the many, many challenges the company faces, with future financing taking center stage as I have noted many times in the past. But there are certainly many other challenges for CYDY as well. PRO 140 is a good drug and it should allow the company to meet those challenges but it will still be quite an adventure getting this company to the finish line.
I also had one other thought that shareholders should consider. There is now $5 million in debt due in January 2018. A portion of that is owned by the CEO. I suspect the rest is owned by friends of his. Should shareholders be concerned that the strategy may be to let CYDY go belly-up and then the debtholders get the company's assets while shareholders and warrant holders get wiped out? I doubt this is the CEO's first objective as I suspect he is a honorable fellow, but it is likely his back-up plan if the company is unable to raise the needed cash. If so, he might not have been taking as big of a personal risk as we first thought when he bought the convertible bonds.
Yes, the dossier should indicate the issues/questions the FDA wants the panel to vote on.
I don't think we can know for sure what the FDA will want the committee to vote on until the dossier comes out (other than approval, of course).
I imagine it will be on the company's website but it certainly will be on the FDA website. I will post a link to it if I see it on Bloomberg before others find it. If you want to pay to listen the to the actual Ad Com proceedings on the 26th, go to FDALive.com
Theratechnologies and it happened in May 2010.
I can't say for sure but I am pretty sure we will be able to access the dossier early on the 24th, if not late on the 23rd. We may not get a sell-off on the dossier's release, but I have seen it happen before. It all depends on the tone of the document and the skittishness of the investors reading it (as well as their knowledge of how these things work).
I once saw a stock fall 50% on the dossier's release and then get a 17-0 vote in favor of approval by the Ad Com 3 days later leading to all that ground being quickly made up and then some. It rarely is that extreme but don't be surprised if there is a sell-off on the 24th.
The big question in my mind is not the phase III primary endpoint results, which I assume will be good but the financing that is yet to come. It seems clear to me the weekly cash raise of $1 million or so is just a patch to get the company to when it can do a larger cash raise on the back of the good primary endpoint results (and perhaps breakthrough therapy). My concern has long been that this could be a very significant and dilutive equity offering. Alternatively, and perhaps more sensibly if they are confident in the results, they could try to raise a smaller amount, say $15 million, now and then raise a lot more later when they hope the share price is higher due to monotherapy results being available.
It will also be interesting to see if the FDA requires a second phase III trial for both combo and mono. If so, all the time lines get stretched out and the need for funding is much, much greater.
Definitely. It is almost a certainty that the stock will move dramatically one way or the other. In fact, beware of a big move on 7/24 when the FDA will release its dossier on Rexista for the meeting on the 26th. Many investors are inexperienced with Ad Com hearings and the dossier is usually filled with info that sounds like the FDA is really concerned about the drug. Actually, they are just trying to present the most difficult issues the drug presents to the panel of experts and are not likely anywhere near as negative as it might sound by reading the dossier. So, I would not be surprised if the stock got rocked a little on the 24th. But I do expect a pretty favorable meeting on the 26th and the stock could really jump if I am right about that.
You need to look more closely at Ibalizumab as you have some seriously incorrect information about it. There is no need for CYDY fans to worry about Ibalizumab or vice versa at this point. So there is no reason to trash either drug by either side
15-20 minutes versus 3 minutes. Some have said the IV has to be administered in the hospital but Thera is arranging to have nurses administer Ibalizumab at the patient's home or office if the patient desires.
The name of their drug is Ibalizumab and it is targeting patients that are resistant to three classes of HAART (multidrug resistant or MDR). It is similar but it works on all tropisms of HIV whereas PRO 140 works only with the one which accounts for only a small piece of the MDR market. The FDA granted Ibalizumab Breakthrough Therapy and Orphan Drug status and recently accepted Ibailzumab's BLA, giving it Priority Review status and a 1/3/18 PDUFA date (although most expect it to be approved much earlier than that). PRO 140's combo test looks a lot like Ibalizumabs, but the FDA refused to give PRO 140 Orphan Drug status (apparently because it sees PRO 140 serving a market larger than the MDR market) and has yet to finally rule on BTD for PRo 140. Both drugs work well and have no side effects. Ibalizumab will initially be administered by IV once every two weeks but should be available in an intramuscular injection form about 12-15 months from approval. Pro 140 is a weekly subcutaneous injection.
Both drugs should eventually play a role in treating HIV patients (assuming the phase III data for PRO 140 looks good) but Ibalizumab will be doing so shortly and will likely be relegated to the small MDR market for quite some time, if not forever. PRO 140 should have a much broader market available to it and this seems to be where the FDA is pushing the drug. So, perhaps PRO 140 could be used in patients with just one or two resistances in combo therapy - this is a much larger market than the MDR market. If that is where PRO 140 ends up, it will be very lucrative for the bulls here. If they also get approved for monotherapy (much harder to accomplish, but the data so far seem to indicate that might be doable) then CYDY is a huge, huge winner.
Also, there is a small possibility Thera and CYDY team up. Thera has the sales force CYDY needs and CYDY would be able to keep much more of the sales from PRO 140 if they did a deal with Thera to market it, just like TaiMed (Ibalizumab's developer) did. If they partner with a big pharma company, they will get far less in royalties, but they would still do very well.
But, we need to see the phase III combo data looking good as this trial seems more challenging than past PRO 140 trials and CYDY needs to get its finances in order. My guess is the data will look good but the financing issue should keep everyone here very nervous.
I have consistently talked up PRO 140 for monotherapy. I have consistently said the drug works well and its tests should continue to show that. I have consistently said CYDY has some really big financing hurdles, which is pretty obvious and that it would be best to buy after the last big capital raise has occurred (or maybe participate in it). I have consistently said Ibalizumab is a superior drug to PRO 140 in MDER patients and the facts bear that out. I am just reporting it as I see it and I know that sometimes makes the bulls hear feel a bit bad but I am not a basher. And, you would have done well to buy Theratechnologies and not buy CYDY over the last year, so I should get a little credit for being right, don't you think. I am happy to debate and learn about these two drugs, so feel free to make your points as well. Should I question your bullishness as being somehow biased as you are questioning my concerns about CYDY? I don't - I just share info that I think would be worthwhile and any fair reading of my posts would indicate they have been very useful. You are free to ignore them but I prefer if you raise good counterpoints so I can learn - that is the purpose of these boards. I have consistently said that if CYDY can navigate the financial challenges it faces and get PRO 140 approved for monotherapy, it has a lot of upside. If it can, I hope to be along for the ride as it should be a very big ride higher. But anyone can see that the company is on the ropes financially at the moment. I expect it will survive but worry current shareholders could pay a big price in the process. So buying later rather than sooner seems sensible to me.
It will depend on the label the FDA gives the drug. For combo, the label will likely be for multi-drug resistant patients. I can't see how doctors would be able to prescribe off label for that and this is the market that Ibalizumab will dominate. Since there are not many MDR patients that will qualify for the use of PRO 140 due to their tropism, it is really going to be difficult for CYDY to find enough revenues in this already small segment of patients.
Once the Mono trial is completed and the drug is approved for that, the label will be really, really important to determine how large the market will be for monotherapy. Hopefully, the FDA gives it a broad label and allows for widespread usage. It would make sense for them to do so based on what we know right now. But the label issue is going to be a big deal for monotherapy.
The problem with off-label usage is insurance won't cover it. Since PRO 140 is likely to be an expensive drug, there will not be many who can afford to pay for it themselves, thereby limiting off-label usage.
If you had 2.3 million shares shorted on IPCI, would you really want to hold that position in front of the Advisory Committee meeting. Not unless you are crazy as Rexista is just what the FDA is looking for right now. Therefore, I suspect this run is all about the shorts covering.
You all might be interested in this:
http://www.valuewalk.com/2017/07/opioid-epidemic/?utm_source=dlvr.it&utm_medium=twitter
Recently, someone posted a link to a Seeking Alpha report on opioids which was very comprehensive but overlooked IPCI. In paging through the voluminous comments section to the article, someone asked the author about IPCI. Here is his reply:
"Author’s reply » Philip Mause, thanks for the question about IPCI. I am aware of them. My reservations stem from a statement by a scientist about the chemistry/science being a problem and my own business concerns about management. I will leave it there."
Does anybody here have any idea about the chemistry/science problem he claims might exist? Also, any thoughts on his concerns about management?
From my perspective, everything is coming up roses for IPCI right now and his complaints are largely unsubstantiated. But i am looking for different perspectives from those of you who have been following the company longer and closer than I.
The recent fundraisings are either an indication of desperation or a attempt to raise the most minimal amount necessary before going for a much larger offering once the primary endpoint data is available. Or it may be a combination of both. There is no reason to expect bad primary endpoint data based on historical results (although the phase III combo test is more difficult than the phase II). So, on balance, I have to think that while the small, desperate-looking June fundraisings are concerning, all will be well in the end, at least for the company. The big question now is how large of a fundraising will the company need to do once the good combo primary endpoint data is available? If I am management, I want to do a large amount which would be very dilutive to current shareholders.
If they continue with a never ending series of smaller raises, it might be better for shareholders on the dilution front (assuming the stock price rises over time) but it is also like water torture - drip, drip, drip.
In any event, we should know the answer to the company's strategy regarding raising the needed funds in about a month or so.
Short blurb from a Mackie report today (bolding added by me):
Rexista Should Be The Best-in-Class Oxycodone and Grasp Decent Market Share: We believe regulations for opioids are likely going to be more strictly enforced based on recent FDA events (the FDA asked Endo to remove Opana ER from the market and issued a complete response letter (CRL) to Egalet regarding the prior approval supplement (PAS) of Oxaydo, as well, a public FDA meeting on July 10th and 11th is also to be held regarding
opioid drugs with abuse-deterrent properties). We believe IPCI’s Rexista has the most disruptive technologies to prevent opioid abuse in the category of oxycodone to date and based on that it should obtain a decent share in the opioid market once launched. We expect Rexista to be U.S. launched in 2018 after IPCI resolves the patent dispute with Purdue. IPCI
needs to find a strong U.S. marketing partner to showcase this product.
IMPACT – Maintaining our SPECULATIVE BUY rating and US$6 TP
try searching on FDAlive.com
Just so everyone is prepared for the ad com meeting, a few days before the FDA will release a dossier on the drug which will include questions for the panel to address. Some investors in the past have mistaken these questions as criticisms the FDA has of a drug. BAsically, it is just the issues they want the panel to discuss to get their feedback on them and may not be suggestive that the FDA is unhappy with the drug. I once saw a drug stock fall by 50% when the FDA's dossier was released simply because the market mistakenly read that the FDA was critical of the drug and approval was not going to happen. The Ad Com panel then voted 17-0 in favor of approving the drug and the stock quickly gained back all it had lost and then some. So, if the way the FDA has worded things in its dossier first gets you worried, take a minute to consider that they are trying to stir up the discussion with the Ad Com panelists and are not necessarily being critical of the drugs prospects for approval.
I was thinking it would be in August. It looks like the FDA wants to push things forward faster than expected. Which is not surprising given the extent of the opioid crisis and the new FDA commissioner's efforts on this front.
Remember, about 9.5% of IPCI is held by short sellers. Don't be surprised if they try to push the stock price down today and tomorrow in order to make their quarter end reports to clients look better.
On my timeline that puts mono commercialization out to late 2019, that assumes the FDA only requires one phase III trial. However, thy may very well require two phase III's and that put commercialization out to late 2020 assuming they require another 48 week test.
Moreover, this would also likely mean they need more cash to get to the finish line and, therefore, more dilution.
Does anyone know if the company thinks they will get by with just one phase III trial?
Wire: Bloomberg News (BN) Date: Jun 28 2017 6:01:01
Life After Opioids: Drugmakers Scramble to Concoct Alternatives
By Caroline Chen
(Bloomberg) -- In the wake of mounting overdoses and deaths
from the opioid-addiction crisis sweeping across the U.S.,
drugmakers are racing to come up with safer painkillers.
Companies are highly motivated to create alternatives to
the $4 billion opioid market. The federal government is cracking
down on lax prescriptions that contribute to many thousands of
deaths a year and has started to block the sale of medications
it considers unsafe.
Drugs such as morphine, fentanyl, and oxycodone are such
powerful analgesics because they so effectively block pain
signals by acting directly on the brain. Since they work at such
a fundamental level, these medications would be perfect
painkillers were it not for their tendency to cause addiction.
“In medical school, we used to play this game: If you could
only take five drugs to a desert island, what would they be?
Everyone would say morphine because it’s such a terrific drug
for pain,” said Morgan Sheng, vice president of neuroscience and
molecular biology at Roche Holding AG’s Genentech unit.
Drugmakers are tackling the challenge from all angles,
working to create an arsenal of medications tailor-made for
different forms of pain. These new drugs are drawing from the
known pain-modifying attributes of chili peppers and cannabis,
as well as human genetic mutations that alter how people
experience pain to concoct new treatments for the nation’s 100
million chronic sufferers. One of the more far-out medications
in development is derived from a deadly toxin found in cone
snails.
Many of these new innovations are intended to treat
osteoarthritis pain, a huge market as the baby-boomer generation
ages. Centrexion Therapeutics Corp. is developing an injection
using synthetic capsaicin, the active ingredient in chili
peppers. A mid-stage trial showed a single injection in
patients’ knees brought significant relief for as long as six
months.
Read more: How the opioid crisis unfolded -- a QuickTake
Explainer
Capsaicin reduces the hyper-sensitive nerve endings in the
knee, "like a hair cut," said Centrexion Chief Medical Officer
Randall Stevens. The nerves will eventually grow back, requiring
repeated treatment. The drug has the added benefit of not
affecting nerves that sense touch and pressure, so the joint
will retain some normal sensation, minus the most active pain
sensors, said Chief Executive Officer Jeffrey Kindler.
Other new arthritis meds are nerve-growth-factor
inhibitors, which block pain signals in nerve cells beyond the
brain, such as in skin and muscle. This drug class was dogged by
concerns that it worked so well, patients overused the affected
joint. That led the U.S. Food and Drug Administration to issue
temporary suspensions of some early trials. Pfizer Inc. and Eli
Lilly & Co., which co-developed one of these drugs, have
adjusted doses and now have the leading treatment, called
tanezumab, which received fast-track review from the FDA on June
13.
Taking another tack, Genentech is developing an oral drug
based on extremely rare genetic mutations that prevent people
from feeling pain. Studying them helped scientists discover a
pathway in the body called the Nav 1.7 sodium ion channel that’s
implicated in pain. By modulating the pathway, Genentech hopes
its pill can tamp down suffering.
Cannabinoid Receptors
It’s still early days. The drug, called GDC-0310, just
completed a Phase 1 safety trial. Genentech’s Sheng said he’s
hopeful it will have few serious side effects since humans with
the mutated gene are otherwise normal, save for a loss of the
sense of smell. Sheng said it should be effective against
musculoskeletal pain, such as in the lower back. Amgen Inc. is
also in the early stages of developing a Nav 1.7 blocking drug.
Other pre-clinical treatments include Cara Therapeutics
Inc. and Centrexion experimental drugs that target the
cannabinoid receptors, mimicking the analgesic effect of
marijuana. Meanwhile, scientists at Hunter College in New York
are working to make an intravenous painkiller based on a toxin
found in cone snails.
Opioids probably won’t ever be shelved for good -- they’re
just too potent. So a handful of companies are working on
versions that are safer and less addictive. Nektar Therapeutics
has created an opioid that’s designed to cross the blood-brain
barrier very slowly, which results in a lowered euphoric effect.
Because of its slower entry into the brain, however, the drug
won’t be able to help with cases of acute pain. Nektar is
developing it for patients with chronic lower backaches.
Trevena Inc., meanwhile, is working on a safer opioid for
hospital use that doesn’t slow patients’ breathing like many
current opioids do. Said CEO Maxine Gowen: "We’re all longing
for the day when a non-addictive pain therapy with no side
effects comes along, but until we find that perfect drug,
opioids will continue to have a place."
Even if mono gets enrolled by the end of the third quarter, you still have almost a year for the trial to be completed, then it takes quite a bit of time for a company to compile the trial results and put together the FDA application. Then the FDA will take at least six months (the practical bare minimum) to produce their decision on mono. For Theratechnologies, which had only a 40 person phase III trial for Ibalizumab, which has the BTD, it took them six months from the end of the trial until when they submitted their application to the FDA. So you have a year from the last patient enrolled just to complete the trial and likely a year for the application to be assembled and for the FDA to review it. You might pick up some time because it is a second indication (following the hoped for earlier combo approval) and because PRO 140 might receive the BTD too, but that is already reflected in the optimistic info I stated above. It is more typical for these things to be delayed than to move faster than expected. Even after approval, it takes a little time to get labels printed and get the drug on the market. CYDY will be relying on a partner for marketing and timing will not be in their control. History suggests that there are a lot of ways new drugs get held up longer than any investor feels is reasonable as they make their way to the market.
So, you better be counting on late 2019 for Mono commercialization. Anything earlier than that would be a fortuitous break.
I see other posters are counting on a buyout before that anyway. If the drug is as good as we think, then the last thing you want is a buyout as that will mean current investors will be transferring meaningful value to the buyer that they could have had themselves. This could be a huge drug and there is no way you want it to fall into someone else's hands.
If Mono completes enrollment in 4Q17 and then has a year to go before the trial is over, then the company has to get its results assembled and filed and then you have to wait for the FDA to approve it, you are talking about many, many quarters before Mono is approved. Like late 2019 at the earliest.
The nice run in the stock recently likely reflects both the impending completion of the combo trial enrollment and the equally impending share offering. Underwriters typically push a stock higher before the offering is announced in order to get their client (CYDY) a better price. Since we already know the drug works well, the enrollment completion is nearly equivalent to the primary endpoint being reached. We will get the official verification of the primary endpoint data being good likely a month or so after enrollment is completed.
The big question in my mind right now is what type of offering is on its way? Will it be for a small amount of money (say $15 million) or for a larger amount ($25 - $50 million). Either way, it will be highly dilutive. What is not yet clear is if that will matter much to the stock price If the money raised ensures financial stability all the way through commercialization, the market may then see the financial risk in the stock as largely gone and react positively (after an initial hit to the share price). New management usually likes to take the hard medicine up front, so don't be surprised if the offering is large. On the other hand, it may still be too hard for the company to raise a large amount of cash at this point and they may have to continue to opt for smaller offerings until they are closer to commercialization.
Actual Q2 numbers are not important. What management says about Q3 and beyond is what will be important in the Q2 earnings release. Bloomberg is estimating they report on 7/13.
Great work figuring that out!
IPCI has little cash and very good potential products that could and should be invested in. So it would make sense to raise new cash by selling shares to stabilize the company's balance sheet and provide funds for Regbatin trials.
The presence of this brokerage firm could well indicate an equity offering is being considered.
One potential unexpected positive that could help them raise the needed funds would be for the Mono trial to be enrolled much faster than anyone expects it to be. It should be much easier to enroll for that trial and they seem to have been making good progress with it. What if they announce it will be fully enrolled by August or something like that. It could make a huge difference for the upcoming fund raise and I suspect such a surprise is not out of the question. Since Mono is where this company will make its money, this is where they should be spending the most effort. They are only going to use the combo results to push the Mono therapy and yet I think we all have been looking at it the other way around.
At the same time, you should expect a very large raise that will be very dilutive if this is correct. After that fund raising, depending on how much they raise, the company might well be a decent investment opportunity.
The FDA is removing Endo's opioid Opano ER from the market. It will be interesting to see the reasons and fallout from that for IPCI. It should be positive given Rexista is a solution for Opano's problems, but the market is weird, so you can't be sure.
There were a whole lot of shares given out and they are in the money immediately. So that is additional dilution. But I suspect it is again meant to convey hopefulness about the future in the run-up to the much larger and dilutive share offering that has to be forthcoming.
While dilutive, the offering is necessary and is in the best interests of current shareholders as the alternative is to go belly-up.
It would be helpful to all if you were more specific.