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Here is what I am guessing about the sequence of events:
1.) CEO buys $1.15 million in converts at $0.75 conversion price to instill investor confidence.
2.) We get encouraging comments from company and its representatives this week at conferences, to further build investor confidence and push the share price higher prior to a larger offering.
3.) Company announces the final patient has entered the Combo trial.
4.) Shortly thereafter, the primary endpoint data is released. I think it is fair to assume it will be good.
5.) Very quickly thereafter, a new equity raise is announced for a sizable amount. The new CEO does not want to go forward without sufficient cash in his pocket. Current shareholders will get diluted heavily again, but it is really the best case scenario for long run success.
6.) Another offering may not ever be needed as there are so many warrants that might convert as the company succeeds with their tests and the share price rises. But there will still be a ton of dilution coming from that. Even so, current common shareholders should still make money of the tests go as well as I think they might. Nowhere near as much as you might hope or deserve given the risk you are taking, but still a nice return.
Good combo results and a bigger offering are right around the corner. The purpose of the CEO buying is to build investor confidence in the upcoming offering. The underwriters will point to his buying and say if he is a believer, you should be too. That may or may not be true but, at a minimum, it is a good marketing approach for the upcoming offering. They may be able to get more money in the offering with less dilution because of the insider buying. I am just wondering how legal this is. Surely, the CEO has material inside info. But given the state of affairs and how small the company is, neither shareholders or the SEC may care about that.
Low cash is definitely a negative for the stock. At the same time, it is hard to see how they run out of cash, especially now. So, while this is a negative, it likely is becoming less of a negative each day. The ATM dilution is way less than the dilution you would get with a larger offering right now so it is hard to argue with the company using that option to bridge them to the place where they are cash flow positive. And the use of the ATM should be slowing in Q3 if not halted altogether. The alternative in the last couple of years was to just go belly-up which I think all can agree would have been really dumb given what potential their drugs have.
It would be great if we already had a partnership in place for Rexista and I suspect many like me thought we would by now. In fact we thought they would a long time ago. We do know that the delay can't be more than 30 months, but that is along time. so, the inability to project revenues fro Rexista anytime soon is a real negative as well. But, as you are aware, that is likely to be cleared up much before 30 months, either through a settlement with Purdue or by the lawsuit being completed well before 30 months (Collegium's lawsuit with Purdue lasted only 6 months someone else has mentioned here previously). So, there is definitely room for positive surprises on that front.
Charts are pretty much useless as many an academic study has shown, so I don't count that as a negative.
Offsetting all that is any number of positive developments. While IPCI is not risk free, it sure looks a lot better now than it has in a long time. While there are risks, the return side of the equation looks very interesting as well, which is why I imagine you have a position again.
This is essentially a small bridge loan until a larger financing can get completed. I am not sure how $1.15 million is enough. If they did such a deal, does it indicate desperation? If this is all they could raise with a conversion price of $0.75 on the notes and $1.35 on the warrants, what does this tell you? I wonder who the buyers are. Unless there is another shoe to drop soon, it tells me they needed money fast and were willing to take even a small amount with the hope of making it the next offering, which likely will come right after the combo primary endpoint is available. But they must have been out of money now and had to do this.
Can you please list the negatives you see?
What this new report means is that Opus is the firm CYDY will likely be raising money through in the next raise, which is likely imminent.
The analyst fails to acknowledge the very small number of CCR5 patients available in the multidrug resistance market since almost if not all MDR patients, by definition, have had HIV for a long time and have migrated to to the CCR4 strain where PRO 140 does not work. It is likely such a small market that CYDY should just not spend any additional money on the trial as they will find it hard to find a marketing partner for such a small market. I imagine the only reason to continue is to get the Breakthrough Therapy Designation and that is significant.
On mono therapy, PRO 140 has a real chance at success if its big phase III is successful and I suspect it will be (assuming they can raise the money to complete it). While it has advantages over HAART with regard to once a week dosing and the lack of side effects, it is also not quite as effective. But it may be effective enough for many. The analyst states that it may allow users to "take a break" from HAART. I don't think that is likely since stopping therapy is the main thing that leads to becoming resistance to a drug. Doctors are very reluctant to have their patients stop taking HAART drugs that are working for fear the may develop a resistance to them and not be able to use that drug ever again.
The shorts are working hard - they are up to almost 9% of the float now. Clearly, they are betting on an offering as their escape route. Normally, I might think they are smart as most company's would have an offering to enable the company to get moving on PODRAS and Regbatin. But with the company likely generating free cash flow, Odidi may just choose to wait until they get cash out of a Rexista partnership before getting going on PODRAS and Regbatin trials.
That may not be in anyone's long term economic best interests, but it would not surprise me at all if that is what happens. In order to maximize shareholder value in the long term, it might be best to just get on with the testing, which will require more money than they are likely to generate in Q3, Q4 and beyond. But Odidi does not want to lose control of the company so he may not do a highly dilutive share offering.
Then again, there may be a more creative way to go about getting the money. Maybe they sell rights to Seroquel for cash. Maybe they settle on more attractive terms than we would like (more attractive for Purdue) and get cash that way. Time will tell.
Meanwhile, the shorts are in control until the company provides evidence that there is no hope for them. Being cash flow positive in Q3 and beyond is likely not going to be sufficient to drive them off. A quick settlement/partnership with Purdue would do it, however. Or raising money in some other manner that does not allow the shorts to get out.
Lupin just announced Seroquel approval
The corruption at the FDA might be economically motivated if the people at the FDA who screwed this up have anything to do with the shorters who have been offering usurious sums to borrow our shares. It seems those shorts knew something, doesn't it?
I am not trying to talk down PRO 140, just state the facts (and sometimes opinion as well) as I know them for the benefit of all. That is what a message board is for. If you have facts or opinions that contradict mine, please go ahead and post them and we will all be better off for it. Each person has to choose for themselves which they want to believe in the end and that is how it should be.
Have a great day too!
Actually, I thought I disagreed with you a fair amount and wanted the board to know my perspective so that no one was misled. But you are certainly right that we all want good solutions for HIV patients. Hopefully, both drugs will be approved and many will benefit. I believe there is a pretty good chance PRO 140 will be given the Breakthrough Therapy designation by the FDA as the combo trial results will likely be good enough to do so and the FDA should want to help CYDY to raise the money they need to continue testing PRO 140. The FDA gave Taimed the designation at a similar point in its history (where they needed to raise funds to continue testing Ibalizumab) and I suspect they will be inclined to do the same for CYDY.
Here are my comments on your statements about Ibalizumab:
Your statement: Ibalizumab will be live saving for patients CCR5 negative , with resistance to HAART.
My comment: Correct. More specifically, it will be used for patients with multi-drug resistance, which means resistance to at least three of the five classes of HAART.
Your statement: It is CD4 inhibitor , and most probably sooner on the market than Pro 140 , but IMO not a very big competition to it.
It is giving as an IV injection every two wks. So patients need to go to clinic or hospital every 2 weeks for IV infusion.
My comment: Ibalizumab has already been filed by Taimed (last week) is a Breakthrough Therapy drug and therefore will be given priority review. It will likely be on the market this Fall. Pro 140 has not yet completed it Phase III combo trial, which looks very much like Ibalizumab's yet the company does not talk about it being for MDR patients. It hopes to get Breakthrough Therapy status on the basis of those as yet undetermined Phase III combo results. Time will tell if it will get that, but they have a decent chance of getting it. Even so, it will likely be 2019 before PRO 140 gets on the market for combo therapy (primary endpoint in 7/17, test completed in December, likely filed with the FDA in March 2018, likely approved in November/December and finally on the market in early 2019). And the first mover advantage for Ibalizumab is going to be very significant. Moreover, the MDR market has very few patients who who are CC5 that PRO 140 addresses since treatment experienced patients (which are what all MDR patients are by definition) have migrated to the CC4 version of the HIV virus. Moreover, Taimed's partner Theratechnologies is arranging for a nurse to come to your home or office to give you the infusion. These are the reasons CYDY is downplaying the combo therapy trial and Ibalizumab's extended access program may be one of the reasons they cannot find patients to get into their trial. The other reasons are they can't find many CC5 patients because few exist and further, apparently one of the trial requirements is that none of their patients have previously used Marivorac (or something like that) which almost all their potential patients have likely tried to use in the past as it is a CC5 drug as well.
Your statement: From TaiMed web....."Phase 1/2 clinical trial of SC and IM injection started in 2012 in Taiwan for HIV positive and HIV negative patients.The current available
UN- AUDITED data show tremendous antivirus activity "
All together studies are done as an adjunct treatment only.
My comment: Correct, Taimed has tested only in combination, with an optimized background therapy (OBT) in phase III. They have not pursued monotherapy as that is pretty unconventional in the HIV space.
Your statement: I exchanged few e-mails in the past with Dr Chen from TaiMed , and according to him they not planning monotherapy for HIV positive patients. Monotherapy they doing study only with HIV negative , high risk patients as a prevention.
My comment: As noted above, monotherapy is a very unconventional, high risk concept in treating HIV patients, so this is why Taimed has not pursued it. If it works for CYDY, it will be a huge win for them and the stock price will go nuts on the upside, but the accepted form of treatment in HIV is to outfox the virus with a variety of therapies. But it has a chance of working since most new HIV patients start out with the CC5 version of the disease.
Your statement: With adjunct phase 3 ( 30 patients total ) they have 36% patients accomplished <50 copies/mil viral load.
If we looking at Pro 140 , even without adjusting the dose 62.5% patients on monotherapy did very well , with many patients <1copy/mill viral load. With adjunct I expect even better.
One patient stop Ibalizumab because developed some immune problems . This is not happening with Pro 140.
My comment: The patients in Ibalizumab's study were very, very sick. So sick that 4 of them died from other causes before the very short trial could be completed. They started with extremely high viral loads and Ibalizumab greatly exceeded the primary endpoint in getting that substantial viral load under control very quickly. Ibalizumab's results were great and no one should think otherwise. That is why it is a Breakthrough Therapy and orphan drug that the FDA clearly likes a lot. PRO 140's results were not for such sick patients so you cannot compare them. PRO 140 may get Breakthrough Therapy but it has not as of yet. To try to convince anyone that PRO 140 is superior to Ibalizumab at this point is not a good idea and the facts don't back that assertion up. It is clear the FDA does not yet think so and they have access to much more info about the trials than we do.
Your statement: For those reasons IMO Pro 140 is superior with CCR5 positive patients.
My comment: Unfortunately, you cannot make that claim yet. We need an apples to apples test and that is what the phase III combo trial is. In fact, PRO 140 needs to beat Ibalizumab's results in its combo trial and it may do that, but we will have to wait and see. EVen if it does, for MDR patients, CC5 patients are likely only about 10% of the total and Iblalizumab works on both CC4 and CC5. With the head start Ibalizumab will have over PRO 140, is it any wonder that CYDY is turning investor attention to monotherapy now? If PRO 140 is not really a whole lot better than Ibalizumab in the maybe 10% of MDR patients who have CC5 tropism, then why will doctors use it? And who would partner with CYDY to sell it to such a small market?
The future for PR 140 is in monotherapy, which is a very high risk/high return situation for investors. If they can be successful there, shareholders might ultimately be handsomely rewarded for the dilution they will need to endure to get there. But it is a high risk gambit.
They have not moved on from the adjunct trial because they need good results to get Breakthrough Therapy status and they need Breakthrough Therapy status to be able to raise the money for the mono and other trials. So, they are proceeding with the adjunct trial, not so much for the market that awaits them, which is small at best, but for the BT status and the ability to raise the needed capital to remain alive. If that strategy does not work, it is not clear they have a fallback position.
Also, they are free to enroll for mono and the adjunct trial is not hindering that. Money, the lack thereof, is hindering that.
They would give an update on enrollment if the numbers were good. The fact that there has not been an update should concern you.
I am sure they are hoping to raise a little money via Sheen and his Hollywood connections in order to complete the adjunct trial and then hope to use BReakthrough Therapy to raise much more serious amounts of money in a more conventional fashion.
A lot has to go right for it all to work but I would not count them yet. The drug works and they very well could get Breakthrough Therapy status. The question for shareholders is what is the cost to attain all this? It could be high and it certainly does not seem like it will be low.
I agree. If the company has not announced it, then it is best to assume it has not received final approval yet.
Mackie is reporting that Seroquel has received final approval.
Shorts are still looking for shares based on feedback from brokers. I have to assume they are positioning for a sale of new stock to use as their exit point. The company may be heading into cash flow positive territory soon but it will not likely be generating enough cash to pursue further drug development on Regbatin and PODDRAS. So, a new raise may be coming after the good news we expect in the coming weeks/months is out, but the shorts need to be worried that that fundraising could be at a significantly higher price than what now exists.Shorts currently account for 2 million shares or 8.2% of the total. So we can also expect those shorts to be messing with the share price as it is not too hard for them to do.
Since they have been losing on this argument already, is it safe to conclude this is all just a delay tactic?
do you have a link to that?
Only if the Odidi's are interested in selling. There is no way a potential acquirer would buy without both the Odidi's being happy about it.
It looks to me that they will dip into the Paulsen well one more time to complete the combo, hope that gets good primary endpoint data and a Breakthrough Therapy designation, thereby allowing them to raise more money at hopefully higher prices.
It all comes down to the label for combo. The combo trial looks very much like the Ibalizumab trial for what they call Multi Drug Resistant (MDR) HIV and which Tony called salvage patients. If the label restricts them to patients in this category, which I believe it will, those outside the 20-25,000 in the salvage category will not be able to access PRO 140 unless they are willing to pay for it out of their own pocket. Moreover, PRO 140 compares unfavorably to IBalizumab in that market because of the fact that most salvage patients have the tropism that PRO 140 is ineffective on.
This is why Tony said Mono therapy is the future for them. I am not even sure they could find a marketing partner for PRO 140 if the FDA restricts them to the salvage market.
Unfortunately, yes, you are missing something. If the FDA approves PRO 140 for combo therapy, the label it gives it will be a big issue because insurers will not reimburse patients for its cost if it is used of label. So, if the label is narrow, it could constrain the use of PRO 140 in the manner you have suggested. ANd it almost certainly will be narrow because the label follows the trials typically. That is why they are doing a mono trial - in order to be able to access the broader population of HIV patients via that approval.
That is much better patent protection than I thought was the case. It seemed to me this drug had been around for quite a while before CYDY took it and really tried to develop it.
I have not looked at the patent aspect of PRO 140 but perhaps someone else has info of worth. One reason the loss of the Orphan Drug designation is significant is that it brings with it 12 years of marketing protection that is effectively better than patent protection. Since they did not get that, then the patent's rule and I don't know how much time is left on them. DOes anyone have the answer to that?
I would add that CYDY's chances of selling much PRO 140 in the combo therapy (salvage) market is not high. Since treatment experienced patients are the only ones in that market, most are R4. So, PRO 140 is ineffective for most patients in that market. They will have trouble finding a partner offering them attractive terms to market PRO 140 in the salvage market because of this. This is no doubt why management focus is now more on the monotherapy market since most newer HIV patients are R5, for which PRO 140 is effective. Monotherapy is also a much bigger market, so that is hopeful, but it will take the company a lot of time and money it does not presently have to get monotherapy approved. If they can find the money, I would not be surprised if it did get approved.
Also, I would point out a partnership is also dilutive as CYDY would have to exchange some of the revenues from the drug with whomever they were partnering with. The number of shares would not increase in a partnership but the revenues received per share would.
Finally, the amount of money needed to get to monotherapy approval is likely going to prove greater than they suggested. That amount was just to get the current trial completed. Also, the full amount of money needed will be greater than $60 million since the CFO also said they will need some unspecified amount of funds to cover SG&A costs too.
I have to believe some way will be found to get PRO 140 on the market but I can't really say it will be in a manner that will help current shareholders.
My take is the management team is very confident of ultimately getting very good trial results from mono and that is their main focus. They also will get BTD but it is unlikely that approval can be achieved on mono before mid to late 2019. Combo will be completed but they can't really compete with Ibalizumab in that market, which will have a big head start on PRO 140 anyway. So, getting an approval for that will be only a small victory. And if we want them to succeed at one of the two, it is definitely in mono. I have always believed in PRO 140 as a drug, but my main concern has always also been the dilution current shareholders will have to endure to get there. People, that dilution is going to be quite significant. The company is clearly hoping that a good primary endpoint data on combo therapy will give the stock a boost and allow them to get off an offering that will not be too nasty to shareholders. Ut the reality is they need too much money and the dilution is either going to be heavy or very heavy. Those are really the only two options. If they come up with a partnership, that too will be dilutive as they will be exchanging future revenues from the drug for some payment now or in the future (or both).
Also, there is a small risk the combo trial does not come out as nicely as they are hoping. When you start with really sick patients, the progress seen in the trial could come up short of what was seen in prior trials where the patients were not as sick. Still, it should be sufficient to get some excitement about approval and allow an offering to get the company to the next step. But there will almost certainly be further dilution after that as well. They have already outlined nearly $60 million in needed funds and you know that will prove to be too low. So my advice is to keep your expectations low for the stock price over the next year or two as dilution will limit the upside until the market perceives that the mono therapy will be approved. Then it will rocket.
Hopefully, the company was getting the bad news out early with the ODD announcement and will follow that up with good news tomorrow of receiving the BTD. If they do get BTD, that will significantly aid them in their capital raising efforts. I have to believe the FDA sees enough promise in PRO 140 to give them the BTD designation. The FDA should want to help the company raise the needed funds to pursue the final round of testing on PRO 140 as they clearly would like to see new therapies reach the HIV market.
IF they get BTD, the dilution should be much less. If they don't, it will be harder to raise the new money at attractive price levels.
With TaiMed, the FDA granting the company BTD and ODD really helped them raise the needed money at a key moment in the development of Ibalizumab. I have to believe the FDA will grant BTD to PRO 140 too. You can be sure the FDA noticed the ability of TaiMed to raise the needed funds after getting those designations.
I am referring to getting hammered by huge dilution.
For those suggesting I am using drugs or casting a black cloud on CYDY, I am just trying to be realistic. If you are unaware of the need for further dilutive financing, you are simply not doing your homework (and reading the 10-Q). I said a long time ago that the time to be in this stock is after the last large dilutive financing and, unfortunately, this has not yet occurred. I feel sorry for those of you who have hoped for better, but it is patently obvious the diluting is not yet done - the company tells you straightforwardly in the 10-Q. It is just a question of how much dilution and when.
The drug seems to work well enough to get approved, but for shareholders to make a nice return, it takes financing as well to pave the way to approval. And current shareholders should be hoping for some additional dilution as the alternative is their investment goes up in smoke. My concern is the new guy opts to wipe the old shareholders out and set himself up for success with new shareholders who end up owning the vast majority of the company's shares for ponying up major dollars - enough to get the company through approval. That is a lot of money and would mean major dilution. It is an inescapable fact when you add up the numbers the company has provided. I am not trying to ruin your day but am instead trying to help you see the reality of the situation in current CYDY shareholders face. Hopefully, I am at least somewhat wrong and new financing can be found in such a manner as to keep dilution to a minimum. But I doubt that can be achieved, I suspect the warrants will never be exercised as the share offerings that are needed will end up driving the stock price quite low and a big reverse split to get the stock price nominally higher will ultimately mean the options will be so far out of the money that they will never be converted.
After reading the 10-Q, one has to wonder if a new share offering of significant size is coming. The drug likely works well enough to be approved but the only way to achieve approval is to raise quite a bit more money. The answer might be to issue some kind of convertible preferred share that effectively hammers the common shareholder with its conversion ratio. That is how they might be able to attract sizable funds at this point. The enormous number of shares and warrants are a huge impediment to a proper fundraising for CYDY and something highly dilutive to those who have hung on and suffered this far may be the only reasonable way for the company to proceed. Again, with a new sheriff in town, I would not be surprised if he takes the old shareholders out and shoots them and starts afresh with a new dominant shareholder group (the convertible preferred shareholders). It would be ugly but it makes sense as it may not be possible to continue to raise money piecemeal via Paulson much longer. For the long-suffering longs, I hope this is not the case but it is definitely a big risk at this critical juncture for CYDY.
It is good news as it indicates Rexista is relevant or they would not be concerned enough to sue. We also know IPCI will prevail. And this was expected. In the end, this may open the door to a settlement with Purdue where the two companies end up partnering as Purdue realizes Rexista is a real problem for them and they would be better off keeping their "enemy" close.
I have no idea what might be announced on 4/18 but I do know when a new guy is made the boss, he has one chance to reset the table to increase the chances for his success. He can make radical changes and blame the previous boss for the pain shareholders must endure as a result of those changes. So, often, everything but the kitchen sink gets thrown overboard in these situations. Again, I don't know what might be announced but every CYDY shareholder should be aware of the possibility that good news is also accompanied by bad news. The biggest risk, in my view, is for really huge dilution to current shareholders as the new boss tries to clear the decks of the financial problems the company faces.
If they sent notice of suing IPCI over Rexista, the company would have to announce that. No announcement, no suit. Since today is theoretically the last day they could notify IPCI of their suit, I think we will likely have to wait until Monday to be sure there is no attempt by Purdue to interfere with Rexista's launch. If there is no PR on Monday, then Rexista may be on the market sooner than anyone no thinks and the door would be open to a quicker partnership.
Shorts are up to 8% of the float. They are undoubtedly expecting a share offering as their way of getting out. And they could be right if a partnership deal is not signed that brings some upfront cash. ut I suspect one will be signed.
This is encouraging - have to believe we will see a quick approval of Rexista:
Wire: Bloomberg News (BN) Date: Apr 5 2017 13:15:15
Opioid Epidemic Is FDA’s Top Priority, Says Pick to Head Agency
By Anna Edney
(Bloomberg) -- Opioid painkillers that have led to
thousands of deaths and new drug addicts should be the highest
priority of the U.S. Food and Drug Administration, said Scott
Gottlieb, President Donald Trump’s pick to lead the agency.
“The opioid epidemic in this country has staggering human
consequences,” Gottlieb said Wednesday in a hearing before the
Senate Committee on Health, Education, Labor and Pensions. “I
think this is the biggest crisis facing the agency.”
Likening the widespread abuse of opioids to the outbreak of
Ebola virus that ran rampant in West Africa, Gottlieb said that
the agency would have to pursue a number of paths, such as
working with drugmakers seeking approval for alternatives and
abuse-deterrent versions of the drugs. More than 33,000 people
died from opioid overdoses in 2015, according to the U.S.
Centers for Disease Control and Prevention.
The agency would “push the policy boundaries” for approval
of safer opioids and other alternatives if he’s confirmed,
Gottlieb said. “It’s going to be an all-of-the-above approach.”
Gottlieb is likely to be confirmed by the full Senate when
he eventually gets a vote. His comments to the committee
Wednesday seemed to assuage concerns by some senators on the
drug crisis as well as other issues, including potential
conflicts of interest that come from his work as a consultant
and investor.
Number of Hats
A former FDA staffer who left the agency to work in the
business world, Gottlieb also faced questions on his ties to
health-care companies. Financial disclosure forms show he earned
millions of dollars from various investment banks and
pharmaceutical firms last year and in the first part of this
year, including $1.85 million for his work as a managing
director at T.R. Winston & Co., an investment bank that raised
money for a number of public companies.
“You do wear an extraordinary number of hats,” said Senator
Patty Murray, a Democrat from Washington.
Gottlieb replied that at the FDA, he would be guided by
science. If confirmed, he would resign from T.R. Winston, divest
interests in more than a dozen companies and temporarily recuse
himself from making decisions on at least 20 more where he has
financial interests or was paid consulting fees, including
GlaxoSmithKline Plc and Bristol-Myers Squibb Co.
“The lives and the futures of families like mine are
affected by the decisions made by the FDA,” Gottlieb, whose
wife, children and parents were at the hearing, said in his
opening statement. He pledged to make sure “the FDA puts their
interests first in everything we do.”
Drug Prices
Gottlieb has previously spoken about lowering drug prices,
a Trump priority, by speeding approval of generic drugs. He’s
particularly focused on complex medications that combine old
drugs with newer delivery devices, as well as those with
unusually complicated formulations.
In his prepared remarks, Gottlieb urged rejection of what
he called a “false dichotomy that it all boils down to a choice
between speed and safety.” Instead, he wrote, if the FDA
leverages new technology and better science it can improve
efficiency and safety “and also remain faithful to FDA’s gold
standard for regulatory conduct.”
Gottlieb, 44, served as a deputy FDA commissioner from 2005
to 2007. He hasn’t faced the same criticism from Democrats that
other Trump administration choices have, such as Health and
Human Services Secretary Tom Price and Supreme Court justice
nominee Neil Gorsuch.
In addition to his consulting and investment work since
leaving the agency, Gottlieb has also been a fellow at the
American Enterprise Institute, a conservative-leaning Washington
think tank. He was trained as a physician and completed his
residency in internal medicine at Mount Sinai Medical Center in
New York after graduating from the Mount Sinai School of
Medicine in 1999. He earned a degree in economics from Wesleyan
University in 1994.
To contact the reporter on this story:
Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story:
Drew Armstrong at darmstrong17@bloomberg.net
John Lauerman
Note that may be of interest from a research report:
TRx for ENDP’s generic version of Seroquel XR were 16,745, down from 17,431 in the prior week, and volume share stands at 46% (19 weeks after its launch on 11/1/16).
I am not sure what you are talking about. I suggested a long time ago that Theratechnologies (THERF) would be a better bet than CYDY and it has more than tripled over the last year and is up over 100% this year. I also like IPCI, which might have been what you were referring to, but it is not in the same area as THERF and CYDY. IPCI is more complicated than THERF or CYDY but it could be a huge winner as well. CYDY could be a huge winner too but it has huge hurdles to overcome to get there. If they can get the BTD, that may help them raise the extra funds needed to finish the trials. There is still huge dilution to contend with, however. But if they are able to finish the mono trials and get approved, then CYDY could well be a moonshot, regardless of the dilution.
My best guess is they are not getting BTD and they are going to have good results for the primary endpoint for the adjunct phase III. So, they are likely not going to announce the BTD not coming through until they can also announce the good primary endpoint results. Then they will try to leverage off the good primary endpoint results to raise the needed money to complete the mono phase III. Perhaps by convincing some who have warrants to convert. If not, then you are likely looking at another dilutive round of financing, likely with even more warrants issued. But they need to keep the Mono trial going to have the safety data the FDA requires for the adjunct to be filed and approved.
Two snippets from a research report I saw this morning that may be of interest:
TRx for ENDP’s generic version of Seroquel XR were 17,431, up from 15,612 in the prior week, and volume share stands at 45% (18 weeks after its launch on 11/1/16)
Xtampza ER prescriptions trending higher (COLL). TRx's for Xtampza ER, COLL's abuse-deterrent form of oxycodone ER, totaled 1,164, up from 1,069 in the prior week. Recall that COLL signed a number of contracts with key payers in 2H16. Based on the most recent week of Rx data, we estimate that sales are now annualizing to $13M-$14M,assuming a gross-to-net spread of 40%-45%.
The Phase III trial on Ibalizumab and the earlier trials on PRO 140 were very different in that the patients on Ibalizumab were much less healthy to start with. If the two drugs had similarly sick patients, you would likely have similar results in terms of efficacy. This will likely be true when PRO 140 reports its Phase III adjunct trial results as well. Ibalizumab has been tested as a monotherapy and the results were not all that different from when the OBR was used, so, that does not appear to be much of a factor. In fact, it was a monotherapy trial up to the primary endpoint in phase III as the OBR was added after that.
Additionally, there were really no side effects or drug interactions with Ibalizumab. I have seen some references to there being some, but there are not any.
PRO 140 is a good drug, but Ibalizumab is going to be the one doctors use for MDR patients. PRO 140 might find a very nice home elsewhere in the HIV market and it might be a much bigger home than the one Ibalizumab will dominate in the small MDR space. But its road to get there is going to be challenging due to competition in those spaces and the company's disastrous financial situation. The question for investors is even if PRO 140 surmounts the hurdles and becomes successful, will current shareholders be diluted so much in the process that the returns are weak? It sure looks that way right now.
Also, I doubt GILD is thinking very hard about taking over either company. The MDR market is too small for GILD to be concerned about and they likely doubt that PRO 140 will make it to the market for financial reasons (not being able to fund their trials).