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Affymax, Inc. (AFFY) Message Board

hugeman99 16 posts  |  Last Activity: Apr 10, 2015 10:41 AM Member since: Jan 21, 1998
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  • hugeman99 hugeman99 Apr 10, 2015 10:41 AM Flag

    Thanks for info, assuming RTH258 PhIII results mimic PhII, and strictly from the view of a patient, I think reducing injection frequency from 2 months to 3 months would be a really big deal, This patient population (elderly) really doesn't like to go to a doctor any more than they need to. (this topic was debated at length on this board over the last 18 months and I know there are many widely varied opinions, even those in the ophthalmology field)

    As far as investing, I'm more thinking of it from a REGN short perspective longer term. If Eyelea is no longer the preferred treatment for wet AMD, etc.., then pricing would seemingly have to drop to maintain market share. REGN shares right now are priced as if the Eyelea golden goose will live on forever. I know REGN has the hypercholesterolemia drug in late stage trials, but now it looks like even that will have competition from a an oral treatment versus subcutaneous.

    Shorting REGN can be a risky trade as Sanofi has big checkbook and regularly buys REGN shares in the open market. Interesting enough they've never paid over $400/share and haven't bought any shares since late last year. Evidently even Sanofi thinks REGN shares are overvalued.

    === Posology, I learned a new word!

  • WamdGuru are you familiar with RTH258 from Novartis/Alcon? It's just starting PhIII in wet AMD. Back on 2/27 they announced what appear to great PhII results. I'm just not hearing much about RTH258, any idea why?

    Essentially they're saying they only had to inject RTH258 every three months vs Eylea every 2 months and that they achieved endpoint of non-inferiority. Are these mid stage results as good I they seem to be?? Eylea essentially upended Lucentis with it's reduced dosing frequency. Do you think RTH258 can do the same thing to Eyelea? Could they end Eylea's dominance in retinal diseases?

    Here is excerpt of 2/27 P.R.

    ===========================================
    Basel, February 27, 2015 - Alcon, the global leader in eye care, presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting in Scottsdale, Arizona. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular (wet) age-related macular degeneration (AMD). RTH258 (formerly known as ESBA1008) is a novel, single-chain antibody fragment developed to treat wet AMD.

    The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity (BCVA), from Baseline to Week 12. ............ more...

  • Reply to

    Results out..... SWING AND A MISS!

    by hugeman99 Mar 27, 2015 7:04 AM
    hugeman99 hugeman99 Mar 27, 2015 12:19 PM Flag

    Hey dumb #$%$ loser, blow it out your Arsssssss. And don't hate me because you took a beating on this stock and I made a boatload last year. Hate yourself for making bad trading decisions. You can join Optimist_77 in his misery.

    And just in case you are as stupid (and ignorant) as you come across, you can't attend a shareholder meeting unless you hold shares on record date of meeting.

    So, just to be clear, (to those with at least a modest IQ, I think I am clear), I bought a whopping 100 shares a few months ago as my ticket into this years meeting. It's done by a lot of smart traders. The trade didn't set up well and I didn't go to the meeting, which I've already said.

    I'm sorry if I didn't sell the shares the day after the meeting record date and ahead of PhII results to make YOU feel better, my bad. Otherwise I had no position in the stock going into PhII final results. The mention of the 100 shares was intended as sarcasm.

    Learn to plan your trades, do the necessary leg work, then trade your plan. You'll make more money that way.

    And as for attending last years meeting, where I had the opportunity to meet L10 and a few other shareholders, why would I share what I learned with jerks on this board unless it was to my advantage? You want the info, go to the meeting yourself.

  • Reply to

    Results out..... SWING AND A MISS!

    by hugeman99 Mar 27, 2015 7:04 AM
    hugeman99 hugeman99 Mar 27, 2015 7:11 AM Flag

    By the way that was me who unloaded my 100 shares for $8.15 at 7:04am

    (Had to own 100 to give me potential acces to shareholder meeting.)

    It's all yours L10!

  • But boy are they talking in circles to make it look like there is something there!

  • Reply to

    OHRP

    by johnlas464 Mar 11, 2015 10:27 PM
    hugeman99 hugeman99 Mar 12, 2015 6:43 PM Flag

    THAT would have been a good question for the shareholder meeting! Oh well.

    Hard to brush off that question without looking bad.

  • The shareholder meeting just started.........

    I couldn't even muster up the motivation to go down to NYC for the meeting this year.

    You'll recall, they hold the meeting at their lawyer's office (how fitting) and the tenor of the meeting reflects it. Last year, most shareholder questions were met with the response 'we haven't disclosed that information' and a bunch of hand waving from the lawyers.

    I don't expect him to tell us, but I doubt L10 is going this year either.

    (Maybe Optimist_77 will go to the meeting and give OHRP management a piece of his mind!)

    Other than wanting to ask why they are not increasing squal concentration and/or dosing frequency in PhIII, there wasn't much reason to go. At last years meeting a shareholder asked about potential for increasing frequency/concentration and Dr. T's answer was.... 'we don't think we need to'. Now that interim results missed the original primary endpoint by a country mile, I don't think he can give that answer with a straight face.

  • Looks like the company may have actually played their cards right with the sketchy SHRM data press release. It seems they woke up a whole bunch of people who were playing the interim results last year. Perhaps now traders are rolling the dice on final PhII data at the end of the month.

    Has anyone else noticed that there seems to be a renewed interest speculating in small cap biotech? Is this a seasonal thing? Unless that tone changes before data is released at the end of the month, I'll reiterate my belief that if the final PhII data is consistent with interim data it will be well received by the market in the short term.

    Greed seems to be trumping fear at the moment.

    Did anyone hear anything new/significant in the Cowen presentation yesterday? I didn't.

  • Reply to

    WHere is ADAM F.'s Hate Twit?

    by jg7320 Mar 2, 2015 8:44 AM
    hugeman99 hugeman99 Mar 2, 2015 7:40 PM Flag

    As best I can tell, Feuerestein, as much as he hates OHRP, couldn't even muster up a Hate Tweet! All I could find was a response to someone else where he referenced links to his previous Hate Articles! Nothing new.

    I'm no expert, but it seems that what OHRP announced today is pretty sketchy. No specifics, no statistical data (even if it is retrospective). And I can't tell if it's data based on ALL participants or a select few that OHR submitted for analysis.

    Feuerstein seems off his game lately. He's been tweeting much less and with less enthusiasm. I doubt it's all the snow in Boston that is holding him back. Maybe he's drying out after a drinking binge?

    A few weeks ago he made a couple of nasty tweets where he went head to head with his boss (Cramer) on ISIS and AGEN.

    I wonder if the Boss Man put the self absorbed alcoholic in his place?

  • Reply to

    Where are the phase II results?

    by wamd_guru Feb 19, 2015 10:54 AM
    hugeman99 hugeman99 Feb 27, 2015 1:28 PM Flag

    Based on shareholder expectations and original primary endpoint the interim results were awful.

    Livermore10's overly optimistic posts on this board and anecdotal website commentary by doctors involved in the trial had people expecting a significant reduction in number of injections. That didn't happen.

    I haven't kept up with Ophthotech and how comparable the trials & results are, but have heard those criticisms. So maybe OPHT is overpriced base on results to date? But remember, with OPHT you are buying a biotech company with an R&D department capable of generating many potential drug candidates over time. With OHRP you are buying a single asset, squalamine. At this point I would consider the ownership of Slakter's SKS assets and trodusquamine as side shows worth very little.

    The potential revenue selling Squal strictly for Visual Acuity gains versus reducing injection frequency are orders of magnitude different.

    I'll reiterate that based on empirical evidence to date there appears to be something to squlamine, but how efficacious it is and WHY are not at all understood by OHRP. Remember, all of the detailed analytical data about squalamine and it's supposed mechanism of action were generated by Genaera's R&D department.

  • StuartCreekFarms, I'm guessing you've seen the results of a PhII trial of RTH258 in Wet AMD announced by Novartis/Alcon today?

    Essentially they're saying they only had to inject RTH258 every three months vs Eylea every 2 months and that they achieved endpoint of non-inferiority.

    Are these midstage results as good I they seem to be??

    Eylea essentially upended Lucentis with it's reduced dosing requirement. Do you think RTH258 can do the same thing to Eyelea?

    ===========================================
    Basel, February 27, 2015 - Alcon, the global leader in eye care, presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting in Scottsdale, Arizona. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular (wet) age-related macular degeneration (AMD). RTH258 (formerly known as ESBA1008) is a novel, single-chain antibody fragment developed to treat wet AMD.

    The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity (BCVA), from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness (CSFT) as measured by spectral domain optical coherence tomography (SD-OCT). Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.

  • Reply to

    Where are the phase II results?

    by wamd_guru Feb 19, 2015 10:54 AM
    hugeman99 hugeman99 Feb 20, 2015 9:19 PM Flag

    Easy now, my fellow skeptical one.

    If you relisten to the 2/9 Qtrly conf call, you'll be reminded that they actually have completed the last dosings in the PhII trial and they expect to announce results 'BY THE END OF MARCH 2015' (my emphasis added).

    Strange that they didn't announce the end of treatments as they did at interim. That would have been a cheap way of proppoing stock price & generating some stock market interest.

    They expect to initiate PhIII in Wet AMD by end of first half of 2015. Two identical trials, Lucentis plus squalamine versus Lucentis plus placebo. 9 month trial. Primary endpoint is visual accuity.

    Also expecting results of Retinal Vein Occlusion Trial by end of June and results of Diabetic Retinopothy by end of June.

    Lack of any insider buying/selling gives us no clues. Stock price action is equally unimpressive.

    I have no illusiions of overly positive results, but if they can match interim results it will likely be well received by the market over time. As I've said before, it seems like there is something to squalamine, albiet somewhat underwheming in efficacy. That said there are many many many biotechs desperate for a potential $1B drug to add to their pipeline.

    Lots to see in the next 3-4 months. We sit and we wait....................

    Sentiment: Hold

  • Reply to

    Groundhog day????

    by hugeman99 Feb 6, 2015 8:51 AM
    hugeman99 hugeman99 Feb 6, 2015 4:12 PM Flag

    Speaking of Groundhog day, how long will it be before the ever irritable and much poorer Optimist_77 rears his ugly head?

  • Reply to

    Groundhog day????

    by hugeman99 Feb 6, 2015 8:51 AM
    hugeman99 hugeman99 Feb 6, 2015 4:05 PM Flag

    Let me be clear, I still think doing the offering at this point is a negative for likelihood of unexpected good news when final PhII data hits. What it says to me is that management doesn't have a 'clear' idea of how final PhII results will turn out and they are being smart and filling the cash coffers to keep their jobs alive in the event there is a negative surprise.

    My gut feel is that second cohort is relatively consistent with first which leaves likelihood of good PhIII results and ultimately FDA approval a big giant maybe. Not a place I like to place bets.

  • Reply to

    Groundhog day????

    by hugeman99 Feb 6, 2015 8:51 AM
    hugeman99 hugeman99 Feb 6, 2015 3:49 PM Flag

    wamd_guru, per the analytical data we've seen, I'm as skeptical as you, but have you considered the idea that squal has some level of efficacy, albeit modest & via a not yet understood mechanism of action?

    Ahead of interim results Livermore_10 (practicing MD, no idiot) pontificated on the science around why squal was going to knock the lights out & it all made sense, But interim results proved him wrong. Which begs the question... Everybody is now saying that squal DOESN'T work because lesions weren't reduced, injections weren't reduced, etc.... Maybe squal is having some effect on the lesion or other factors of wet amd that improve acuity.

    Although interim data was questionable at best and statistical significance was on the bubble, if the results of the second cohort are consistent with the first it will reinforce statistical probability that something good is going on (even if not well understood) it's going to be more difficult to call the overall PhII results a one-off.

    That said, who cares if it doesn't reduce injection frequency as long as acuity is improved? If they can get through PHIII with similar results to PHII interim it seems to me the FDA would have no problem approving squal as a supplement to VEGF's.

    I guess the reason I reserve judgement is two fold; the early results of the Genaera PhII squal infusion study showed efficacy before the trial got upended by approval of Lucentis. Second is the backing OHRP has from retina community leaders. These are smart guys with impeccable reputations and boots on the ground who have a sense of what is actually going on at the patient level.

    I don't think PhIII trial design has yet been fixed, but it seems OHRP has plenty of room to increase squal concentration in the drops and/or increase dosing frequency to see if they can eek out some additional efficacy.

    I admire your gutsiness to short at this point. I have no position in OHRP. As always, I'm just hunting for a good trade.

  • hugeman99 by hugeman99 Feb 6, 2015 8:51 AM Flag

    Feels like April 2014 all over again. Issuing shares ahead of final PhII data? WHY if they are gonna be good?

    Will they make another 'strategic' acquisition too?????????????????

    Maybe they'll issue a couple of hypster P.Rs about the enormous potential of Trodusquemine?

    Why haven't they announced completion of the PhII trial treatments? If all went to plan it should have been done in end of January? The announcement would have at least helped prop up the stock ahead of offering.

    Are we having higher dropout rate in the 2nd half of the trial????

    Just not looking good here..........................

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