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Forest Laboratories Inc. Message Board

Ricardouno 23 posts  |  Last Activity: Apr 10, 2014 9:04 AM Member since: Jun 5, 1998
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  • Reply to

    Ricardo - NWBO Trial Design Question

    by nhanduyvo Apr 10, 2014 1:04 AM
    ricardouno ricardouno Apr 10, 2014 9:04 AM Flag

    Nhan,

    I would rather not get mixed up in this epic battle of words between NWBO and AF.

    However, as a general reference, a company before embarking on a Phase III trial should carefully review the primary endpoint of their proposed study with the FDA. They should confirm that the drug will be potentially "approvable" if that sole endpoint is met in a properly structured study. In other words, if the medication meets this strictly pre-set goal then the study will be highly likely to strongly support a "registrational" application and pathway towards full approval and marketing.

    Importantly, then, the trial must be structured IN ADVANCE to be sufficiently "powered" to demonstrate a statistically significant accomplishment of the primary endpoint goal.

    Between what NWBO and AF have said, I still do not have a firm grasp on:

    Whether OS ( more likely ) or PFS was agreed upon as a potentially approval endpoint with regulators prior to initiation of the Phase III?

    Whether the Phase III study is structure / powered properly ( e.g. number of patients ) to demonstrated achievement of the agreed-upon registrational endpoint?

    Because of my lack of insight into the above, my investment is limited and I continue to view this as a complete wildcard speculation.....a lottery ticket of sort with all the associated high risks and rewards

    Mildly mitigating the above, is the fact that the Company is involved in a study with MD Anderson, a well respected organization and favorable status with regulators in Germany.

    Good luck!

    Ricardo

  • ricardouno by ricardouno Apr 4, 2014 2:08 PM Flag

    The long term prospects for this Company have never seemed better.......marketed product, clinical pipeline, finances, licensed technology. A level of desirability and usefulness from drugs that save and change lives and not primarily just small incremental improvements.

    The shorter term sentiment in the Market for Biotechs has seldom been worse.

    At some point an intersection will be met when consideration of the above two issues will create a revelation and the price will stabilize...... and market manipulation will cease in favor of a re-established and well grounded investment thesis.

    Have we reached that point? Who knows!?

    Good luck to all,

    Ricardo

  • Reply to

    Ricardo - NWBO Presentation Today

    by nhanduyvo Mar 28, 2014 1:46 AM
    ricardouno ricardouno Mar 28, 2014 8:24 AM Flag

    nhan,

    I think that's basically it.

    NWBO is such a wild speculation at this point. On the one hand the involvement of MD Anderson and the favorable sanctions by the German regulatory agency gives it a measure of credibility......yet there are vehement detractors out there.

    I for one, am willing to take the gamble with a small holding, as the upside ( if it does occur ) could be considerable......but knowing full well the extreme downside risk as well.

    Of note, regarding the presentation yesterday, was the optimism conveyed regarding their presence at ASCO and the early data ( unknown to us presently ) they will be putting out at that meeting.

    Good luck!

    Ricardo

  • Reply to

    Did I hear right?

    by ricardouno Mar 27, 2014 3:43 PM
    ricardouno ricardouno Mar 27, 2014 3:49 PM Flag

    Thanks for the clarification. So basically, it is "available" to physicians to use, but the company cannot promote it through a sales force..... although it can be reimbursed on sales. Is that it?

  • ricardouno by ricardouno Mar 27, 2014 3:43 PM Flag

    Did the presenter actually make the specific claim that even though the vaccine was not officially "approved" yet in Germany it was, nonetheless, a presently marketable and potentially fully reimbursable treatment?

    Thanks for any clarification.

    Ricardo

  • Reply to

    For What Little It May Be Worth

    by ricardouno Mar 22, 2014 12:08 PM
    ricardouno ricardouno Mar 24, 2014 11:13 AM Flag

    bruter,

    You are welcome.

    These are quite speculative stocks, with high risk, so please do your own careful DD. They represent, for me personally, smaller investments.

    Good luck!

    Ricardo

  • Reply to

    For What Little It May Be Worth

    by ricardouno Mar 22, 2014 12:08 PM
    ricardouno ricardouno Mar 24, 2014 7:31 AM Flag

    bruter,

    I have approximately equal investments in IMUC and NWBO.....I do not favor one over the other. They are both smaller speculative ( higher risk ) holdings.

    Please see nhan's comments regarding an investment thesis for IMUC going forward. The key to IMUC's shorter term success will likely be to uncover a distinctly favorable survival outcome, in the longer "tail" of their phase II, among significant subsets of patients. In that way they can present a legitimate case with regulators to structure an appropriately well targeted phase III and also convince a partner who will finance such a study.

    Good luck,

    Ricardo

  • Reply to

    For What Little It May Be Worth

    by ricardouno Mar 22, 2014 12:08 PM
    ricardouno ricardouno Mar 23, 2014 1:38 PM Flag

    nhan,

    Re: IMUC......I will be brief:

    I was favorably impressed with the CEO's discussion during the Company's most recent conference call.

    That being said, this situation still remains a speculation and quite a bit of a long shot. However, at these low prices, I am "in" with a small investment position that reflects the nature of the gamble.

    Good luck,

    Ricardo

  • For what little it may be worth:

    Wayne Rogers ( formerly of M*A*S*H* ) on Eric Bolling's " Cashin" In " show on Fox just recommended purchase of Seattle Genetics.

    Good luck to all.

    Ricardo

  • Reply to

    Why a buy?

    by mauihope1969 Mar 10, 2014 12:06 PM
    ricardouno ricardouno Mar 10, 2014 2:10 PM Flag

    Just my opinion, but I believe that many of the posters on this board offer analysis, research, opinions and information that is on par and as timely as any on the "Street". Thanks for making this board interesting to read and relevant.

    Ricardo

  • ricardouno by ricardouno Feb 12, 2014 7:59 AM Flag

    For what little it may be worth:

    "Seattle Genetics upgraded to Buy from Hold at Needham
    Needham transferred coverage on Seattle Genetics with a Buy rating from a Hold rating. The analyst said Seattle Genetics technology platform has been validated by numerous clinical data, partnerships, and a successful drug launch which can drive growth and believes Adcetris has upside from label expansions and sees sales of approximately $2B in 2020. Price target is $60. "

    Best of luck to all !

    Ricardo

  • Reply to

    Ricardo - Summary of PSMA ADC Phase 2 Today

    by nhanduyvo Feb 11, 2014 12:58 AM
    ricardouno ricardouno Feb 11, 2014 7:59 AM Flag

    nhan,

    Thanks so much for the follow-up. Those data look promising, particularly in the groups of target specific patients ( especially low NE ). Ultimately, however, it will come down to the clinical tumor responses and, most importantly, survival benefit. However, the data might spark enough interest in a partner to help pursue further clinical development with enriched subsets based on specific bio-marker targets.

    Thanks, again for the information.

    Ricardo

  • Reply to

    Roche RG7596 may go to Phase III ---SGEN ADC

    by ricardouno Jan 30, 2014 6:46 PM
    ricardouno ricardouno Feb 2, 2014 9:03 AM Flag

    sbum55,

    Thanks so much for your thorough research and response to my inquiry. It is greatly appreciated !

    Ricardo

  • Reply to

    Roche RG7596 may go to Phase III ---SGEN ADC

    by ricardouno Jan 30, 2014 6:46 PM
    ricardouno ricardouno Jan 31, 2014 6:27 AM Flag

    atpl1959,

    Thanks so much for that information and clarification.

    Ricardo

  • Does anyone here follow Roche (RHHBY)? One of my sources noted that today on their conference call, Roche mentioned that RG7596 may / might go to Phase III. This drug uses SGEN's ADC technology. If anyone listened to their call and would like to comment and verify the proceeding or supply more specific information on what was said please post here.

    Thanks!

    Ricardo

  • ricardouno ricardouno Jan 30, 2014 4:50 PM Flag

    Nhan,

    The press release looks "promising", especially:

    "For example, reductions in CTC's of more than 50% were seen in over 70% of patients treated."

    Since high PSMA and low NE markers on CTC's seem to correlate with beneficial CTC response....that could prove useful in targeting patient population subgroups in future trials.

    Still, would like to know the clinical responses.......if available at present.

    Will try to grab the conference call, but tonight may be hard due to scheduling.

    Ricardo

  • Reply to

    Recardo - Abstract from ASCO-GU for PSMA-ADC

    by nhanduyvo Jan 29, 2014 1:04 AM
    ricardouno ricardouno Jan 29, 2014 10:19 AM Flag

    Nhan,

    It appears that the trial drug, PSMA-ADC does have some anti-tumor effect in a significant subset of this group of study patients. However, the abstract deals exclusively with laboratory findings, which are customarily associated / linked with the disease process, rather than offering direct incite into any observed and relevant tumor responses. Hopefully, we will get a better total picture when the clinical and radiological follow-up to date is presented at the conference.

    Ricardo

  • ricardouno ricardouno Jan 21, 2014 2:23 PM Flag

    Nhan,

    I have not been following the Progenics ADC drug very closely at all.

    However, based on the reports you cited it does appear that their drug is associated with a notable and varying degree of suppression of neutrophil production. I suspect that this could possibly be due to cleavage of the toxin from the antibody and release into the systemic circulation and then into the bone marrow to exert its adverse effect on neutrophil production. Other possible mechanisms exist. As the very serious and life threatening effect was seen, in the two patients cited, very early ( within two weeks ) after initiation of treatment, subsequent dosage adjustment downward was not apparently an option. As these were chemotherapy experienced patients, it is unclear as to what degree of related myelosuppression was present in each individual at baseline, before treatment, and if this may have been a ( or the ) critical factor in the severity and poor outcome. As the trial is now being expanded into a cohort of chemo naive patients, it will be informative to observe the frequency and severity of this particular adverse effect in that group in comparison.

    Ultimately, the degree of benefit of a drug prospect will have to be weighed against the risks. With very serious or life threatening disorders ( such as metastatic cancer ) the bar of acceptance can be naturally and liberally raised a bit. Also patient selection and timing of initiation of therapy ( e.g. time post chemo to allow fuller bone marrow recovery....as an example ) as well as consideration of initiating treatment at lower doses could become possible treatment strategies to maximize the benefit / risks ratio.

    Looking forward to seeing the ASCO report. Hopefully, that will show a quite notable and very encouraging benefit.

    Ricardo

  • Reply to

    Ricardo

    by frankyassissi Jan 21, 2014 11:29 AM
    ricardouno ricardouno Jan 21, 2014 1:33 PM Flag

    I agree that tumor marker and genetic testing to predict response to different therapeutic options is in the upcoming vanguard of clinical practice. However, I do not presently follow this company nor have any opinion presently.

    Ricardo

  • Reply to

    Ricardouno - Question about ICT-107

    by nhanduyvo Jan 19, 2014 2:27 PM
    ricardouno ricardouno Jan 20, 2014 10:32 AM Flag

    With regards to what I have stated in part I of this discussion, I think it is too early to close the book completely on ICT-107. I believe that further observation of the present survivors ( especially those whose disease has not progressed thus far ) in the phase II study is critical. The best case, arguing for a notable survival benefit would be to witness very long term survival limited mostly or almost exclusively to those on the drug rather than those given "placebo" or other standard of care. That observation may not clearly ultimately fall within the realm of "statistical significance" for the present trial as a whole, but may point towards a high degree of potential clinical relevance. This outcome could be explored in an, appropriately, much larger future study with adjusted patient selection, timing of drug administration and more consistent product manufacturing.

    In terms of an investment, I consider IMUC to be very high risk and a speculative stock. However, I am a bit ( but not overwhelmingly ) encouraged by insider buying of the shares recently combined with what I have discussed above.

    Recently, I have purchased a small bit of shares at about .93 to .95 as a highly speculative investment.......complete loss of capital a distinct and real possibility, with a much lower probability of multiple gains.

    Good luck!

    Ricardo

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