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  • Synthetic Biologics Under The Microscope  [View article]
    Well, thank you very much!!!
    Dec 7, 2015. 07:57 PM | 1 Like Like |Link to Comment
  • Synthetic Biologics Under The Microscope  [View article]
    You point out the uncertainty of 004 goal success and indeed, it is uncertain. That's why its still being clinically trialed. But 004 has a promising batch of preclinical research to support its action goals and a more primitive version of this enzyme showed efficacy and safety in humans as well as protection of existing microbiota. The degree of separation in reasoning you point out was considered in the initial in vitro and in vivo testing on 004 in its older form and in the entirely new batch of preclinical to in vivo testing for the current incarnation of 004. You totally have the point while completely missing the point at the same time. Your question has been an integral part of the 004 investigation from the very beginning and has some answers in microbiota population counts in vitro before and after beta lactam abt exposure, in the animal studies, in the human studies of 004 in its older form and soon in improved delivery form.

    Seres and Rebiotix are both developing human derived microbiota agents for treatment of recurrent cdi. Both are investigating feasibility of developing preventative agents - but they are behind SYN in this most desired development area. C-dif isn't rare. It's the most common nosocomial in US hospitals, effecting more than half a million people in 2011. The CDC calculated that it killed, within 30 days, 1 out of every 9 people aged 65 and over who contracted it that year. Not a small problem and emergence of multidrug resistant cdi adds even more urgency. Prevention is the gold standard goal for this disease. The first company to bring a truly preventative agent to market wins big and is likely to obtain cost-efficient label expansion. The US government has made c-dif prevention a national priority. Treatment is important. Prevention is the ultimate goal. SYN is leading the field.
    Some c-dif info for anyone interested:
    And - the Oxford Journal article references proton pump inhibitor use as a risk factor contributor to the increased rates of outpatient/community cdi. Aren't we all glad SYN is covering that base right now???
    Dec 6, 2015. 09:59 PM | 4 Likes Like |Link to Comment
  • Synthetic Biologics Under The Microscope  [View article]
    You should throw the Baker Brothers a copy of your resume and portfolio. Seriously. A researcher who can grasp the science and business fundamentals in depth and has excellent research skills - that's like gold.
    667 MADISON AVE, NEW YORK, New York, 10065, (212) 339-5600
    Nov 24, 2015. 06:54 PM | 6 Likes Like |Link to Comment
  • Synthetic Biologics Under The Microscope  [View article]
    That was excellent!
    Nov 24, 2015. 05:30 PM | 6 Likes Like |Link to Comment
  • Synthetic's (SYN) CEO Jeff Riley on Q2 2015 Results - Earnings Call Transcript  [View article]
    Trimesta partnership plan is based on recent combo trial for RRMS. No reason for that plan to change and no evidence that it has changed. Cognition trial separate - but given evidence of improvement in RRMS trial, it may be attractive lure.
    Aug 10, 2015. 06:18 PM | Likes Like |Link to Comment
  • AmpliPhi Biosciences - Calling Captain Kirk: The CSO Has Left The Enterprise  [View article]
    Clean up in full force. This will be an excellent speculative investment once this savvy team finishes organizing the new path they have set for the company.

    August 4th 2015
    AmpliPhi Biosciences Cleared to Submit Listing Application to NYSE MKT
    Company Announces One-for-Fifty Reverse Stock Split
    Shares of Common Stock Will Begin Trading on a Split-Adjusted Basis on August 07, 2015
    Aug 7, 2015. 12:58 PM | 3 Likes Like |Link to Comment
  • AmpliPhi Biosciences - Calling Captain Kirk: The CSO Has Left The Enterprise  [View article]
    Really, we're talking about 2 companies here. I'm watching the new incarnation in its earliest stage. Little but the phage tech itself will remain of the old company once this team finishes the reorganization. When current team gives timeline goal for uplist - my count will start. Promises of old team no longer relevant. Knowing that the old team promised such for several years means nothing to me personally. They were not a team I would have considered investing in. Very much like the Adeona/SYN phenomenon. Never would have invested in the first. When SYN team came in - they built a new company out of the old. Slate wiped clean. Same thing happening here.
    Jul 30, 2015. 01:09 PM | 2 Likes Like |Link to Comment
  • AmpliPhi Biosciences - Calling Captain Kirk: The CSO Has Left The Enterprise  [View article]
    It will take a while for the new team to clean up the financial mess. I'm not buying until that is done. If this goes like other interests of Kirk, new team moves in, pipeline torn apart and re-planned, finances cleaned up. This company was one I considered to be uninvestable. It is likely this team will change that. Refinement of phage therapy is happening in a few companies and countries. We will see the new pipeline be based in large part on security of patents and IP, then on ease of development to market ready - if this team follows the formula of other small, messily run biotechs with excellent potential products that grabbed Kirks interest. (I think he plans to be the king of the impending treatment resistant bacteria world). When I took long position in SYN - it was with the mindset of investing in a 'new' company. The entire structure of the company had been completely changed from its prior incarnation under ineffective management. Within months of new teams cleanup - the CSO 'resigned'. In a company that has been promising pipeline development but has really been stagnant - the CSO needs to go too. That person is integral part of bringing pipeline to maturation. If their track record is poor - contract with them to stay for some months after turnover to aide in transition and then let 'em go, with good severance. Its a Kirk kind of thing and it works. Watch patiently. Stay on top of the narrative. Let them clean up the mess. Get in when that's done. Once this technology is refined, it will be highly desirable in this age of dangerous biofilms. Agents exist to alleviate symptoms presently - but we have nothing to cure most antibiotic-resistant biofilms. Our most effective agents leave behind the persister cells of the biofilm - which then just regrow the film again. It's time to put resources into developing phage therapies into safe treatment products. For patent concerns, the company will likely follow patent wrap style of companies that have developed testosterone products or estrogen products. The wrap is heavily method based, covering present and future incarnations, specifying specific individual and families of bacteria their method and phage will target. Its been done successfully already - this patenting of known natural substance already in use elsewhere.
    Good luck to you all. Stay out. Watch the 'new' company develop. Reconsider once they've made sense out of the mess.
    Jul 29, 2015. 08:12 PM | 5 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    "The UCLA-led Phase II study was designed to show statistical significance at 12 months for the MS relapse rate reduction in patients treated with Trimesta plus Copaxone® compared to patients given placebo plus Copaxone®. The trial was only powered to trend toward statistical significance at the 24-month time point. According to the protocol, the results of topline data demonstrate that Trimesta met the pre-specified goal of the study with rapid onset of activity observed for Trimesta plus Copaxone® compared to placebo plus Copaxone®. Dr. Voskuhl and her team anticipated an approximately 29% reduction in MS relapse rate, per the study protocol. A statistically significant 47% decrease in relapse rate was observed at 12 months of therapy (p-value = 0.03 / powered for significance level of 0.05), as well as a clear trend toward a 32% reduction at 24 months (p-value = 0.15 / powered for significance level of 0.10), which far surpassed the investigator’s expectations."

    Average time for patients to begin responding to Copaxone = 9 months. Trial designed for year one statistical significance and year two trend. Study designed long before this new team came in, and designed by UCLA. Not the way I would have done it - but they didn't have evidence base at time of design to designate MRI and GdE lesion measurement as primary endpoints. First year with Copax is basically unsupported year for patients with greater likelihood of Trimesta performing in measurably significant manner, thus the planned interim analysis. A 2010 pr from Aedona :"with a one year interim analysis using standard clinical measures
    of MS disability as well as secondary endpoints of magnetic resonance
    imaging measurements of brain lesion and effects on cognition."
    Year two, with copaxone efficacy to consider, designed to assess trend longevity of Tri efficacy trend in combo. So their stated primary endpoint of a 2 year relapse reduction measurement remains valid. There is no evidence of endpoint change. We have to wait for the study publication before your claim can be supported.
    I am so sick of talking about Trimesta. I've wanted them to shed this legacy since this team came in. But the first year Trimesta effect is very impressive, as is continuation of improved relapse reduction in year two for the combo treated group.
    Jul 18, 2015. 06:05 PM | 1 Like Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    Thanks! I didn't want any bashers to start milking a 'meta' rumor - since they go on and on about what any timeline delay means. They sometimes take words like this and shift context to scare people. That's the only reason I focused on it.
    And...I know you didn't remove it because apparently I posted it on another SYN article here! Oy vey! So - sorry about that. I might be known to get a little overfocused sometimes!
    Jul 18, 2015. 04:21 PM | 2 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    consider author exonerated!
    Jul 18, 2015. 04:11 PM | 3 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    Not a meta. Can be misleading to people to keep saying that. Look in 8k. Consultant hired for MRI analysis. He/She is not collecting MRI data from multiple independent studies to compare with this one. Do you have any idea how long that would take? Probably at least a year - if it was just a few studies and the researchers (plural now - it would take a team to do this) absolutely kicked ass. Thousands and thousands of grey matter pics to compare. Comparison of machines used, evaluation of consistency of tech positioning, comparison of data collection programs used...So lets be thankful that this contractor is conducting full analysis of the MRI data here alone.
    I put 2 definitions up for meta-analysis in my last response to your post. I see that you removed that post. The reason for posting the definitions was to clarify. I question the removal of such a benign post.
    Jul 17, 2015. 10:46 PM | 2 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    This management team has been long been clear about not wanting to develop trimesta themselves. This was their spoken position well before the trial came anywhere near results phase. One thing they would call you on, and Regents/DrV would call you on, is the assertion that the study failed primary endpoints. Both parties have stated on multiple occasions that the study was powered for one year, not two, and all primary endpoints met.
    If you read the 8k, it will become clear to you that MRI results delay is Regents responsibility, not SYN. "They" did not delay MRI analysis. UCal did. Until Regents finished and released that data to SYN (done 07/10), SYN could not sign any sort of partnership deal. You say there is no reason SYN couldn't have had partnership deal by now - and I think I am awfully glad you are not heading acquisitions in any pharm company. You'd be axed in a second if you bought Trimesta blind to data, esp MRI data. In Biotech, late is not synonomous with failed. Late and biotech are constants, in both failures and success. People continuously read into such delays with emotion. If we stick to just the 8k info, we see the party responsible for the delay. We see the agreement to keep data confidential until DrV publishes - a common arrangement between research institutions and pharma companies. We see that SYN made confidential release of data a part of the contract, avoiding negotiation delay now that one full analysis of MRI data is in hand.
    Regardless - I would love to see them unchain themselves from this legacy agent. Distracts from the brilliant pipeline this team has put together.
    Jul 17, 2015. 10:33 PM | 6 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom  [View article]
    I'm so glad my post helped to clarify! Thank you for the feedback - I do appreciate it.
    Jul 17, 2015. 07:54 PM | 1 Like Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power  [View article]
    Analysis vs meta-analysis. Actually an important distinction.
    Meta-analysis - a quantitative statistical analysis of several separate but similar experiments or studies in order to test the pooled data for statistical significance
    Meta-analysis is a quantitative, formal, epidemiological study design used to systematically assess previous research studies to derive conclusions about that body of research. (Merriman-Webster and Ntl Library Medicine definitions, respectively).
    Jul 17, 2015. 07:48 PM | Likes Like |Link to Comment