also biostockz - are you saying that AGN misrepresented the results of the phase II trial conducted on Tav? I am not a doctor but I am a lawyer. If AGN misrepresented material information, that could easily lead to a shareholder lawsuit that could cost AGN a lot more than $50 million! So - did Rodman misunderstand and misrepresent the results of Tav's phase II trial or are you saying that AGN did when reporting the results?
biostockz - I am interested in your reaction/view of snogreen's description of difference between the trial designs for Tb4 and AGN's Tav. Is he correct? Does Tav only have to show safety of drug as to various endpoints, while TB4 has to show efficacy? (I know this description of what snogreen is saying is oversimplified but it is the gist of his argument.)
It seems to me that what you are saying is that Tav's trial resuls were not as good as Tb4's, not that the trial design for Tav was a lay-up compared to the trial design for Tb4.
Comparison of these trial designs is tough sledding for us lay people IMO.
BTW - I am a long in RGRX not a short. I am just seeking a clear understanding of the facts. IMO Tav appears to be our main competition so the difference between Tb4 and Tav is obviously of great importance to all RGRX investors. Thanks
Reflecting some more on this different in trial designs…this will not escape FDA scrutiny. Obviously AGN has to prove the efficacy of its drug. It it doesn't, it won't get FDA approval. IMO it doesn't much matter if efficacy is primary or secondary endpoint … AGN has to meet the efficacy endpoint or at least show AGN's drug performs equal to or better than RGRX's Tb4 to be successful.
I just saw this post now - this is a good explanation. Bottom line - you are saying RGRX has been held to higher standard than AGN has been held to in its phase 3 trials. Certainly not fair! That is a shame if Rodman analyst does not pick this up. We have to prove efficacy with regard to outcomes (as is appropriate in a phase 3 trial); for some reason - AGN only has to show safety, which is a lower bar than efficacy, as to a number of endponts. Hmmmm……Why would Ora desgn the trials so differently and why would FDA agree to "lower the bar" for AGN's new product?
Thank you snogreen for digging into and providing comparison of trials of Tb4 and tavilmiride. Not sure how those differences in outcome measures between 2 trials equate to potential quality differences in products. I do not see anything that shouts out to me "Tb4 is superior to tavilmiride", assuming tavilmirde meets its outcomes (which it already did in first phase 3 trial. A confirmatory phase 3 trial of 400 patients will report in July).
It appears to me that tavilmiride presents larger competitive threat than Restasis.
I see that tavilermide met its endpoints even after CAE (the dreaded "torture chamber"). Results of another large (400 pt) trial are due out in July. I fail to see how Tb4 is in any way superior to tavilermide (other than the NK indication which is a very small opportunity compared to dry eye and therefore discounted by Rodman & Renshaw in its March report on RGRX). I see tavilermide as potentially the real competition here, not Restasis.
Trial results seem pretty good to me. What concerns me more than Restasis is the new drug being developed by Allegan and discussed in R & R's report as follows:
"Of note, in November 2015, Allergan in-licensed from Mimetogen Pharmaceuticals a topical formulation of a novel small molecule TrkA agonist for dry eye disease, known as tavilermide (MIM-D3). Allergan agreed to make an upfront payment of $50 million to Mimetogen and would fund Phase 3 development of tavilermide, which is a small cyclic peptidomimetic of nerve growth factor (NGF), a naturally- occurring growth factor protein in the eye responsible for the maintenance of corneal nerves and epithelium. It induces the production of mucin, a naturally-occurring component of the tear film, and works upstream prior to inflammation. In a previous Phase 3 trial (study MIM-725), 1% tavilermide demonstrated superiority over placebo in both central and total corneal fluorescein staining (change from pre to post CAE) at week 8 (p=0.0134 and p=0.0500, respectively) as measured via the Ora Calibra Scale. Tavilermide also significantly improved common vision- related function symptoms of dry eye disease as measured via the OSDI questionnaire. The drug was well-tolerated, with no serious ocular adverse events. Tavilermide is currently being evaluated in another Phase 3 clinical study for the treatment of dry eye disease. Co-primary endpoints include corneal fluorescein staining and ocular discomfort at day 57. This 400-patient trial is expected to complete in July 2016."
Thoughts snogreen, bocamp and others? thanks.