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  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom [View article]
    http://bit.ly/1fSjhQv
    "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."http://bit.ly/1e7GpIU
    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
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom [View article]
    Absolute agreement here. SYN-004 is the main reason I bought into SYN. After I was in long, they bought the C-IBS agent. Sweetened the deal immensely.
    Jul 17, 2015. 07:42 PM | 2 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom [View article]
    The trial design, created by DrV and UCal, included methods of analysis. SYN is now having second - nonRegent analysis done. This is purely a business move. If outside consultant analysis concurs with the analysis of UCal - SYN has stronger bargaining position. Much stronger. They are removing possible bias, confirming to development partner that data matches what research team purports.
    SYN's licensee status is and has been secure. There is no evidence of any ambiguities in prior contract with the Regents. The push for expansion indicates success, rather than failure. There is no evidence of disagreement about trial data. The 8k shows the path of royalties and payments to UC has been rewritten, more money invested by SYN, more money to compensate Regents for expansion of SYN rights to patents/IP/etc.. The push by SYN to have sole rights to expanded field of use, to be able to offer investing partner the ability to create a larger pipeline, resulted in many meetings between SYN and Regents. Many lawyers. Much contract negotiation. Grueling process as both parties work for maximum gains.They can and probably will offer possibility of expanded development areas to interested party.
    What reason would SYN possibly have to push for expanded patent and IP rights, to now invest so much more money than their original contract with Regents called for, if they have deemed this investment to have failed - or 'gone awry'. This team is sharp. Very difficult to imagine such stupidity from them.
    Jul 17, 2015. 07:38 PM | 5 Likes Like |Link to Comment
  • Synthetic Biologics: Shorts Have Been Burned, Yet Major Catalysts Still Loom [View article]
    SYN renegotiated to increase Estriol patent rights (owned by Regents,SYN via Putney is licensee) in relation to field of use and esp pushed for access to the Regents IP. Without a tight wrap on both, creating agreement for development partner unlikely. Regents made them pay up for this large IP and patent portfolio access - as is appropriate. Regents have invested many years and much money in this research. They inserted increased protections for themselves and SYN paid for increased IP, expanded patent access and field of use.
    8k states complete copy of (Regents) MRI analysis delivery to SYN deadline 07/10. So - they have it.
    Consultant not doing a meta-analysis. No need to bring in any outside independent studies into this mix. The focus is on this study, this data set, these MRI results. That's it. No meta. Consultant specified to be hired by and work as part of UCal's research team, to be paid for by SYN (Putney) with target date of Aug 1 for MRI data being made available. The consultant has access to all of the MRI data and images and is responsible for conducting a separate analysis of results. The consultant will not be working off of UCals analysis, but will be creating his/her own. (wouldn't make any sense to hire consultant if this were not the case).
    It is important for all SYN investors to be aware of the fact that, while SYN agreed to Regents request about not going public with MRI analysis until DrV gets to publish, SYN has no restrictions on sharing data and analysis with affiliates/sub-licensees and potential development partners, regardless of her date of publication. They can't go public but they can go confidential. This means the partner process won't be slowed down. They've removed barriers by improving the IP portfolio, patent access, and no restrictions on sharing info with prospective business partners. Without these improvements, they were unlikely to land a development partner. Their wrap around Trimesta needed tightening. They're in a much stronger and more attractive place now.
    Jul 16, 2015. 11:50 PM | 14 Likes Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    No. They must rule out harm to nonresponders. Will have to provide improved identification of characteristics of responders - which this ph2a is likely to have provided. Think of it like a cancer drug trial. If half population improves because of the drug, but half is actively harmed by the drug, company would need to be able to dramatically improve safety of all participants before FDA supports trial advancement.
    Mar 17, 2015. 06:31 PM | 2 Likes Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    This was phase 2a. Next is controlled 2b. Too many questions at this time for the company to consider commercialization. The criteria specific to their responder pool must be identified first. Without this criteria, they will have difficult time creating successful ph3.
    Mar 17, 2015. 06:26 PM | 1 Like Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    And earliest possible intervention after diagnosis is one of the stated responder identification criteria affirmed by this study and mentioned by Garr.
    Mar 17, 2015. 06:20 PM | 1 Like Like |Link to Comment
  • How Successful Was The Neuralstem Phase II Trial? [View article]
    And microscopic evaluation of the data this trial has accumulated will hopefully strengthen responder identification criteria.
    Mar 17, 2015. 06:19 PM | Likes Like |Link to Comment
  • Synthetic Biologics: A Speculative Small Cap Packed With Power [View article]
    Ballantyine with 200k shares and Riley with 350k are contracted to graduated vesting plan. You may believe they need to buy more, but their vested benefit will leave them wealthy. The 10 year vesting period indicates commitment to company growth.
    Feb 28, 2015. 05:58 PM | 1 Like Like |Link to Comment
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