| Avoid Allos Therapeutics (NASDAQ:ALTH) | | Print | |
| Saturday, 15 August 2009 06:32 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
“Aaron A. writes, ‘I see Allos Therapeutics (ALTH) finally got word of their scheduled FDA panel meeting to review pralatrexate on Sept. 2, which lines up well for final FDA decision of this fast-tracked drug by the Sept. 24 PDUFA date. You still positive on Allos? Where does it trade if it gets approval? Citi has a $15 target. JMP Securities a $20 target, I'm still positive on Allos. The Sept. 2 advisory panel meeting is well timed, since it should allow enough time for the FDA to meet its Sept. 24 approval decision deadline. With that said, don't be freaked out by a short delay. The FDA's on-time record is still not great. The near-term focus, of course, will be the advisory panel. A positive recommendation for approval should be the outcome based on all publicly available pralatrexate data. But then, that's assuming the FDA finds the data copacetic, too. Advisory panels can and do go off script, so the risk is not entirely de minimis. My previous price target for Allos was $11 to $12 a share, so I'll stick with that. Risks? Allos guided to a higher spending (and a higher net loss) for the remainder of the year. Is this a signal that a partnership deal for pralatrexate and/or a takeout are not in the cards? Allos is a small company, so can it sell pralatrexate successfully on its own? Also, in order for pralatrexate to yield significant revenue (relative to Allos' current valuation) the drug has to work in some cancer outside the small indication of peripheral T cell lymphoma. A phase IIb study of pralatrexate in patients with non-small cell lung cancer is underway with data expected in the first half of next year.” Source: TheStreet.com RATIONALE (1) ALTH's lead drug, pralatrexate, was cited to an FDA [ODAC] advisory panel on September 2. As many investors know all too well, this is typically not a good sign. Advisory panels are often called upon to review a drug when there are issues with it. (2) ALTH has still NOT found a partner to help them market the drug. This is yet another negative indicator. CONCLUSION The above factors indicate to me that investors ought to avoid buying shares until there is more clarity with pralatrexate. While the data on the drug certainly appear favorable, the two indicators above leave me feeling very doubtful about its prospects. While I respect his opinion, I think Mr. Feuerstein's call on ALTH may be wrong here. For these reasons, investors should avoid taking any long positions in the company until the results from the FDA advisory panel meeting are announced on September 2. Adam Feuerstein is Senior Reporter at TheStreet.com (Nasdaq: TSCM) Disclosure: No positions. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section Add this page to your favorite Social Bookmarking websites           
Set as favorite
Bookmark
Email this
Trackback(0)
Comments (22)
Hemant
said:
|
After reading Adam Feuerstein's recent article on Allos Therapeutics (Nasdaq: ALTH), investors should stay clear of the stock until there is more clarity on the company's drug, pralatrexate. 
TrackBack URI for this entry
Subscribe to this comment's feed|
... Hello Mr. Hall , I think you are the one who will be wrong here. I am not a fan of Adam F,but I think he will be right here,for a change, AND you will be wrong here, as USUAL. How many guyz do you duped into buying SPPI ? Anyway, Lets wait for Sep 2 and see who is right or wrong. HS |
|
frank valenzuela
said:
|
... ADAM FUERSTEIN LOST ALL OF HIS CREDIBILITY BY REPEATEDLY BASHING HEB AND ALIGNING HIMSELF WITH THAT LOUD MOUTH CRAMER IM SURPRISED U EVEN PUBLISH HIS OPINION SINCE HE SOOOOOOOOOO OBVIOUSLY HAS HIS OWN AGENDA WHICH IS TO MAKE HIMSELF RICH AT ANYBODIES EXPENSE |
|
Hemant
said:
|
... Dear Frank, As I said earlier, I am NOT a fan or supporter of Adam F. This should be obvious if you read my previous comment where I said he could be right, FOR A CHANGE. I know ALLOS has a good product and they committee will vote in favor because of good efficacy and safety profile. The product will get approved by the pdufa +/- few days. Please dont give me HEB crap. The whole scenario is like a complete scam. The PDUFA has passed and no comment what happened with fda other than that due staffing issues at FDA, the response is delayed. HEB was pumped by the team here at biomedreports.com As I said I am not a supporter of Adam F, but he indeed busted HEB and rest is history. I would like to say here that even a broken clock right twice a day !!! Have fun Investing. Do your own DD or else you will get stuck with hype like HEB !!!! No offense to anyone. HS |
|
David Bakke
said:
|
... HEB is hype, huh? Please review the significant institutional acquisitions of HEB shares here - http://www.mffais.com/heb - over the last X months. Follow the money! Getting back to the topic of ALTH. I appreciate getting JmH's perspective that is 'the other side of the coin'. |
|
Hemant
said:
|
... This is to all the HEB enthusiasts: What happened to the Ampligen approval ? If its such a wonder drug or as clamed M.Havrilla et.al, why isnt the govt all over HEB for supplying ampligen, in wake of swine flu epedemic. Answer one question, what happened to the freaking FDA approval? What is the answer ? Wait Wait Waiting Waiting Still Waiting !!!! Hang on tight to your HEB shares, they are going nowhere. With respect to Allos, we will see on Sep2. Its real drug. Atleast we will know the answer YES or NO. Not like HEB where no one knows anything. FDA usually givea answer in approval or CRL. What is the answer with HEB's Ampligen. Instead of arguing with no outcome, lets wait till Sep 2nd. We will come to know who is right, me or J Hall. Good luck with HEB. I sincerely wish you all make money, even considering the fact that you invest listening to pumper without doing any DD. HS |
|
Hemant
said:
|
... Dear David, Follow this link for instituitional holdings. If you want to "follow the money" Alth is better choice !! Also if it matters, Steven A Cohens, SAC brought more than a million shares in last couple of month. Google it if you want. http://www.nasdaq.com/asp/holdings.asp?symbol=ALTH&symbol=HEB&selected=ALTH Another thing about ODAC meeting, The FDA panel usually always meet to discuss new compounds, so to say that "ALTH's lead drug, pralatrexate, was cited to an FDA [ODAC] advisory panel on September 2. As many investors know all too well, this is typically not a good sign. Advisory panels are often called upon to review a drug when there are issues with it" is nothing but senseless bashing. J Hall needs to do some reading before bashing. As I said Sepn 2nd is not too far. HS |
|
Mary Davila
said:
|
... You're the one bashing Mr. Hall. He has done far less destruction unlike that Adam fool. He comes with facts where that Adam guy comes with venom and destruction. |
|
David Bakke
said:
|
... Hemant - it sounds like you have some anger, or maybe excitement, management issues. I'm not sure if it is towards me or HEB. I'm also not sure why your tone is so accusatory and baseless, especially in regards to whether I've done any due diligence since you have no hope of knowing the answer. Maybe I shook the Magic 8 Ball? We can trade tits-for-tats on who's invested in the better stock, and maybe we'll both be right. In the end, I have one tip for you - try and structure your responses and arguments better. To point out the ~$7 million acquisition by a 12 billion dollar hedge fund vis-a-vis the broad based institutional buying I highlighted from the MFFAIS data for HEB is absurd. Secondly, the link you so generously provided actually shows more significant insider selling activity (9 sells, 1 buy) of ALTH whereas with HEB there is significant insider buying actvity (9 buys 2 sells). You see that further corroborates my argument...not yours. We'll see over the next few weeks how it will all play out, but I have to assume your emotional distress is related to HEB and not me since we don't really know each othr. I suggest joint counseling between you and HEB to work through your issues together. You will be happier for it. If the counseling doesn't work, divorce may be an option. |
|
Hemant
said:
|
... Dear David, I am in no way affiliated with Adam F or angry with anyone. I have done very well financially because I dont listen to people who pump stocks or who want to dump stocks. I never had or never will have a position in HEB. I am upset about writing a article without any knowledge. Cmmon how can you say FDA sets up panel only when they see problem with a drug. Justin does need to know that most of the time FDA sets up panel to review new compounds/drugs. Anyway, I hope that many people sell their stocks based on Justin's article so that I can load up more. About the link I send you, it just relates the % of insider holdings. If HEB was so hot, why would there be only about 10 % insider holdings ? Anyway as I said earlier, Sep 2nd is not too far and we will see the results. I think justin wants people to wait untill Sep 2nd to buy. So he wants you too buy at 12 $ not at 7.5. Thats smart !!!! I also want to point out that Adam F's valuations are also way off. He had predicted HGSI to be 10, now its trading at 15. Similarly I think that ALTH will be trading at 15 buy october end. Lets wait till Sep 2nd and then till October end. I hope you make some money on HEB !!!! HS |
|
Hemant
said:
|
... Adam F is short on Osiris Therap (OSIR), I dont believe he is right. I brought about 30 Sep 12.5 calls. I know he might very well be wrong. All I am saying is that all of these guyz have motives. Maybe the want to pump some stocks or they want to dump some stocks. The conflict of interest is always there. Anyway have fun investing. HS |
|
Kenneth Ho
said:
|
... I think this is getting too personal between Adam and Justin, simply because Adam attacked Justin's comments on SPPI, now Justin is doing a tit for tat. By making the above comments, Justin has just lost credibility in my eyes as I would expect him to know that FDA often sets up a panel to review new compounds/drugs. Initially, I thought well of Justin. Now, I'm just disappointed. Bear in mind I'm long SPPI and ALTH. |
|
J.M. Hall
said:
|
... I am sorry for not responding to you all sooner. This is not tit for tat with Adam Feuerstein. Saturday morning, several folks forwarded me the article asking my opinion about ALTH. I have followed the company and am somewhat familiar with the company's drug. To be honest, I was stunned that Mr. Feuerstein was still optimistic about Pralatrexate (PDX). Then again, we just differ in opinion. Just so you know, I withdrew the article from SeekingAlpha. So, it will NOT be published there. It is not my practice to be critical of companies. I'm not a sell-sider. I do NOT and will NOT directly short shares of any company. With regards to ALTH, I was stunned by Adam's optimism with PDX of all drugs as he is the preacher of collaborations and phase 3 data. This caught me way off guard and I felt compelled to offer another opinion. It is my honest opinion. My primary and only concern is the investors, who forwarded me the Biotech Mailbag article as well as the others who follow my articles. It is not, however, important to me whether I am right or he is wrong per se. Right and wrong is not the way to invest. Investors have to manage the risks. I am not knocking the drug or the company. If I were to knock anybody, it would be the regulators. I have watched the FDA screw more companies and investors on drugs that should have been approved - see Nebido June 4, 2008. Historically, ODAC reviews do not end up well, especially the drugs lacking a Phase 3 trial like PDX. I suspect regulators will require another trial before they consider reviewing it. With that said, I certainly could be wrong. The ODAC could make history with PDX. I did some research on PDX tonight and found a statement in the December 2008 article that was published after the ASH conference. Data Early but Promising "The data are early, as this is only a phase 2 trial, but there was a strong enough response to move it forward," commented Janet Burns, MD, professor of medicine in the Division of Hematology, Oncology, and Transplantation, at the University of Minnesota, in Minneapolis. "But this isn't quite a home run, and Dr. O'Connor knows that he will need to combine pralatrexate with other therapies." However, it is exciting to see a potential new agent come on the market for peripheral T-cell lymphoma, she told Medscape Oncology. "We are learning more about the genetic signatures of T-cell lymphoma, and hopefully we can begin to develop therapies specific to this lymphoma subtype." The PROPEL trial was funded by Allos Therapeutics, Inc. Dr. O'Connor was involved in the development of pralatrexate. American Society of Hematology (ASH) 50th Annual Meeting and Exposition: Abstract 261. Presented December 8, 2008. Source: Medscape at http://www.medscape.com/viewarticle/585278 |
|
Justin Hall
said:
|
... PAST EXPERIENCE TELLS ME I am not confident that PDX will be recommended for approval by the panel. I suspect that the ODAC panel is more likely to request an additional study or Phase 3 trial be conducted prior to the drug receiving their recommendation. While the drug does show promise and believe me I do want the company to succeed, regulators are very risk averse and the ODAC panel is notably conservative. Reference: DNDN, GTOP, and others. I've studied many past events and have found that fewer ODAC panel meetings end on a positive note for the smaller, un-partnered and inexperienced drug maker. ALTH is all three: small, inexperienced with regulators and lacking a larger, well capitalized partner. So, I would not be a buyer of ALTH until there’s more clarity on PDX. That’s my honest opinion. It is based on my knowledge and past experiences with the ODAC panel. They are tough. I do not intend to write about the company again. As I said above, it is not important to me whether the outcome is positive or negative. My primary concern was those who follow my articles. As an investor, I make it a practice of hedging all of my positions. So, I would NOT buy shares of ALTH without first hedging them with put options. Puts are like an insurance policy to protect the hard earned money that one is investing. Hemant, I have heard your concerns and frustration. If nothing else, I hope you will consider hedging your position so that you do not get caught in the stampede -- just in case your hunch or guess is wrong. One thing I have learned over the years is that NO ONE can predict outcomes with any certainty – despite how much they think they might “know.” Feuerstein was very clear about the risks associated with PDX. Make no mistake, these risks exist and substantial loss hurts. The smartest guys on the planet can and will lose if they do NOT take the necessary precautions. Whether it is ALTH, SPPI, ARIA or any other company, a smart investor will manage the risks. Reiterating again, I buy put options to hedge my long positions, and up to this point I have never once regretted it. Hemant, my hope is that you will manage the risks for your investment so that you can avoid potentially regretting it later just in case you may be wrong. I sincerely wish you all the best of luck with all of your investments. Justin |
|
Rob Gorgol
said:
|
... Shame - Shame - Shame I rely on the accuracy of biomedreports. ALTH has long been a favorite of Cramer. I don't like him or F-boy. ALTH is a much more likely takeover candidate than SPPI for example (I hold both) and is geared up and ready to market it's own products than most bio's. Considering we pay for biomedreports it's very disappointing to see this become a dispute between organizations. Out of all 20 or more picks on biomedreports which others are recommended not buys at this time? Should ALTH do well it bodes ill for biomedreports credibility and F-boy may finally gain some (unfortunately) credibility. |
|
jq
said:
|
... "(1) ALTH's lead drug, pralatrexate, was cited to an FDA [ODAC] advisory panel on September 2. As many investors know all too well, this is typically not a good sign. Advisory panels are often called upon to review a drug when there are issues with it." Obviously you have NO idea how ODAC advisory panel works. FDA almost always convenes advisory panel when new chemical entity is involved. Pralatrexate is a new one. They also convenes advisory panel when there are potential issues. To assume advisory panel always implies not a good sign is irresponsible, or just don't know how the process works. |
|
greg
said:
|
... I dont see why an AC is a bad sign... We re talking about a PTCL drug here. Not a very constructive comment. Did you even look at the data? |
|
Justin M. Hall
said:
|
... ALL: I am sorry for not responding to you all sooner. This is not tit for tat with Adam Feuerstein. Saturday morning, several folks forwarded me the article asking my opinion about ALTH. I have followed the company and am somewhat familiar with the company's drug. To be honest, I was stunned that Mr. Feuerstein was still optimistic about Pralatrexate (PDX). Then again, we just differ in opinion. It is not my practice to be critical of companies. I'm not a sell-sider. I do NOT and will NOT directly short shares of any company. With regards to ALTH, I was stunned by Adam's optimism with PDX of all drugs as he is the preacher of collaborations and phase 3 data. This caught me way off guard and I felt compelled to offer another opinion. It is my honest opinion. My primary and only concern is the investors, who forwarded me the Biotech Mailbag article as well as the others who follow my articles. It is not, however, important to me whether I am right or he is wrong per se. Right and wrong is not the way to invest. Investors have to manage the risks. I am not knocking the drug or the company. If I were to knock anybody, it would be the regulators. I have watched the FDA screw more companies and investors on drugs that should have been approved - see Nebido June 4, 2008. Historically, ODAC reviews do not end up well, especially the drugs lacking a Phase 3 trial like PDX. I suspect regulators will require another trial before they consider reviewing it. With that said, I certainly could be wrong. The ODAC could make history with PDX. I did some research on PDX tonight and found a statement in the December 2008 article that was published after the ASH conference. Data Early but Promising "The data are early, as this is only a phase 2 trial, but there was a strong enough response to move it forward," commented Janet Burns, MD, professor of medicine in the Division of Hematology, Oncology, and Transplantation, at the University of Minnesota, in Minneapolis. "But this isn't quite a home run, and Dr. O'Connor knows that he will need to combine pralatrexate with other therapies." However, it is exciting to see a potential new agent come on the market for peripheral T-cell lymphoma, she told Medscape Oncology. "We are learning more about the genetic signatures of T-cell lymphoma, and hopefully we can begin to develop therapies specific to this lymphoma subtype." The PROPEL trial was funded by Allos Therapeutics, Inc. Dr. O'Connor was involved in the development of pralatrexate. American Society of Hematology (ASH) 50th Annual Meeting and Exposition: Abstract 261. Presented December 8, 2008. Source: Medscape at http://www.medscape.com/viewarticle/585278 |
|
Justin M. Hall
said:
|
... I'm sorry, but my response had to be divided in two segments. PAST EXPERIENCE TELLS ME I am not confident that PDX will be recommended for approval by the panel. I suspect that the ODAC panel is more likely to request an additional study or Phase 3 trial be conducted prior to the drug receiving their recommendation. While the drug does show promise and believe me I do want the company to succeed, regulators are very risk averse and the ODAC panel is notably conservative. Reference: DNDN, GTOP, and others. I've studied many past events and have found that fewer ODAC panel meetings end on a positive note for the smaller, un-partnered and inexperienced drug maker. ALTH is all three: small, inexperienced with regulators and lacking a larger, well capitalized partner. So, I would not be a buyer of ALTH until there’s more clarity on PDX. That’s my honest opinion. It is based on my knowledge and past experiences with the ODAC panel. They are tough. I do not intend to write about the company again. As I said above, it is not important to me whether the outcome is positive or negative. My primary concern was those who follow my articles. As an investor, I make it a practice of hedging all of my positions. So, I would NOT buy shares of ALTH without first hedging them with put options. Puts are like an insurance policy to protect the hard earned money that one is investing. Hemant, I have heard your concerns and frustration. If nothing else, I hope you will consider hedging your position so that you do not get caught in the stampede -- just in case your hunch or guess is wrong. One thing I have learned over the years is that NO ONE can predict outcomes with any certainty – despite how much they think they might “know.” Feuerstein was very clear about the risks associated with PDX. Make no mistake, these risks exist and substantial loss hurts. The smartest guys on the planet can and will lose if they do NOT take the necessary precautions. Whether it is ALTH, SPPI, ARIA or any other company, a smart investor will manage the risks. Reiterating again, I buy put options to hedge my long positions, and up to this point I have never once regretted it. Hemant, my hope is that you will manage the risks for your investment so that you can avoid potentially regretting it later just in case you may be wrong. I sincerely wish you all the best of luck with all of your investments. Justin |
|
Kenneth Ho
said:
|
... Dear Justin, What you wrote in your your reply to us was more substantial than your initial post. If you had simply validated your opinion as you did in your reply, then fewer misunderstandings would have occurred. Am glad you explained yourself to clear the air. Having said that, the PROPEL study was conducted under an agreement reached with the FDA under its Special Protocol Assessment (SPA). Hence, IMHO, in view of the promising study results and the SPA protocol agreed upon, ALTH has a good chance of a positive FDA panel review. |
|
Gary
said:
|
... The bottom line is investing w a good outcome on your side. justin is doing us a service by warning us of impulse buying on this stock. i appreciate this kind of open discussion w justin responding with some good reasoning. there is lots of $$ to be made out there but you can't do it by being right once and wrong 10 times. |
|
Write comment
Sign Up For Phone Alerts
