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Uhhhhmmmm, no? But really, feel free to tell me that anytime you want! Thanks!
Oh! I think I just responded to you @ stocktwits! I've been member forever, just never bothered posting. Have this week for some reason - just on SYN.
Absolutely my pleasure C! You know I sometimes feel driven to correct misinformation,(is that putting it too mildly???) esp when the misinformation arising from longs can give to much fuel to bashers. So - try to just stay evidence-based and reinforce difference between rumor and the facts we have to work with. This 8k was a doozy though. Basically gave us their entire expanded contract outcome. Yuk. No wonder rumors are spawning. Most people who tried to read it would be asleep after page 2.
This stock is still my largest long position (in my speculative account). Unless narrative changes, I'm here till the company sells. And I am so glad you're here too. :)
It is really impressive that SYN is this strong after their offering announcement, isn't it?
This board is probably going to be very busy for the next few months Boo. It'll be fun for all of us.
This is 8k info re MRI - (g) the complete analysis (the “MRI Analysis”) of a third party specified by Company, which Institution has no reasonable and significant objection (based solely on the fact the retention of the third party consultant would violate any law, regulation, ruling of a court or agency, contractual agreement, or written Institution policy) that is hired as a consultant by Institution and as part of its research team, and which consultant will have full access to all the MRI data resulting from the Study, including a copy of the electronic database containing such images, and will conduct the analysis as generally specified by Company,MRI data being made available not later than August 1, 2015 (costs of the third party consultant will be paid by Company);
(h) complete copy of the actual analysis of the MRI data resulting from the Study existing as of the CTA Amendment effective date, provided to Company by July 10, 2015
So - date of receipt for MRI data and UCal analysis is July 10. Then Aug 1st is next date given for MRI data 'made available'. UCal and consultant have until Aug1 to finish up and hand data to SYN subsidiary. So - this falls within the 30day window given. UC analysis delivered July 10. Full data package with consultants analysis by Aug 1.
DrV already submitted her draft to Syn in June. Publishing at her level - elite grouping of just a few dozen fieldleaders worldwide, can be slow. SYN has no restrictions on sharing data and analysis with affiliates/sublicensees and potential development partners regardless of her date of publication. That's much more important than them going public. As long as they can bargain with potential development partners, we're moving forward. After Aug 1st, they can.
Ups and downs are ahead, but we are in a great little company with management talented enough to bring syn to its potential. A fun ride!
Yup! Beautiful, isnt it?
Frankly C, I have nothing against traders. If I were very chart savvy, I'd do more of it myself. Posers, on the other hand, are a different and unnecessary thing. I love that you expose them with a simple question or two.
That's the initial window given. I imagine we wont be waiting that long though, esp since they bought ip and the multitide of patent rights containing wide variety of potential applications for trimesta. Interested partner has improved security to develop now, and more incentive to make buy attempt later if next partnered trial is positive. I expect we'll here good news soon, but of course thats just a guess.
Grenada? That is awesome! Hope you are having a blast!
No mention of examination of gut flora C, but it is extremely positive that the 004 was confirmed to have no interference with IV abt treatment. And it degraded just where they want it too. So far so good.
Interesting 8k. 12 months to land development partner, as of yesterday. Nice breakdown of terms. Seems to me process so far may have been waiting on aquisition of full intellectual property portfolio and expanded use and patents held by U Cal, which was completed in full yesterday. Makes sense that any potential development partnership couldnt begin until those rights bought and paid for by SYN (or in this case, its subsidiary Putney). Also of note is the fact that Putney will maintain licensee status and partner will be sublicensee. No indication of selling trimesta. And...Univ California likely to make a lot of money on this deal too. Could move very quickly now.
Definitely! Citrati backs up every statement with an in depth explanation of how he's chart reading. Teaches as he goes. Exposes charlatans effortlessly as they cant support their assertions. Engages truly talented chart readers who use different methodolgies in high level, open discussion that benefits all of us. We're lucky to have him here, even when he has bad news!
Nice!
Hi Wiredawg! Truly this board is dead. And this company is a little diamond. Not exciting like the other biotechs though. Now that MRI management is seriously investing in their marketing rep team, we will see adaptation of the tech by hospitals increase in steady increments. A slow, steady grower most likely, but its the best and most adaptable/upgradeable system in the pool of such star-trek surgical tech and suites - it will monopolize eventually. A very long term investment!
Thanks ridin!
Nothing new there for us longs but I loved reading every word! SYN-004 is the original reason for my long position here. Had they nothing else in the pipeline - I would still be in for this agent alone. Potentially huge gamechanger.
I'm guilty of excess quiet C. Sorry! Not enough hours in the day and also just in waiting mode. I do expect that things will get quite chatty once some news comes out. Take care C!
A lot of us who like this company are waiting for the Kirk team to clean up the financials before getting in. Won't be nearing the moon any time soon until that's done. And they will do it - its a consistent kirk m.o.
June 12th 2015 http://ampliphibio.com/
AmpliPhi Announces New Data Demonstrating Anti-Pseudomonal Bacteriophages Retained Biological Activity Following Nebulization
Category: Latest News
AmpliPhi Announces New Data Demonstrating Anti-Pseudomonal Bacteriophages Retained Biological Activity Following Nebulization
Results presented at the 38th European Cystic Fibrosis Conference
San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, June 12, 2015 – AmpliPhi BioSciences Corporation (OTCQB: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, today announced new data demonstrating that bacteriophages remain active against Pseudomonas aeruginosa (P. aeruginosa) after nebulization. Data from this study, performed in collaboration with the Royal Brompton Hospital and Imperial College, UK, were presented at the 38th European Cystic Fibrosis Conference, taking place in Brussels, Belgium from June 10-13.
To determine if nebulization might provide a viable delivery option for AmpliPhage-001, AmpliPhi's program targeting P. aeruginosa infections in Cystic Fibrosis (CF) patients, researchers evaluated the biological activity of four different bacteriophages after nebulization through three commercially available nebulizers. Phages were collected downstream and their biological activity post-nebulization assessed in a standard plaque assay using two P. aeruginosa indicator strains. Phages exposed to non-functioning nebulizer chambers were used as controls. The results showed that all four anti-P. aeruginosa bacteriophages retained their biological activity through all of the nebulizers tested and minor titre drops were within variability of the methodology, confirming that this mode of administration may therefore be appropriate for future clinical trials.
"We are encouraged by these promising results, indicating that the biological activity of bacteriophage against P. aeruginosa infection is retained following delivery through nebulization," said M. Scott Salka, CEO of AmpliPhi. "Demonstrating this proof-of-concept represents an important milestone in our AmpliPhage-001 program, as therapeutic administration through nebulization increases the probability that critical areas of the lung can be directly reached with phages in patients with cystic fibrosis."
The research teams had previously established the safety and efficacy of nasally-inhaled bacteriophage against P. aeruginosa in a murine model, noting reduced infective burden and inflammatory response demonstrated in bronchoalveolar lavage. Based on these positive data, AmpliPhi plans to advance its AmpliPhage-001 program, with delivery via nebulization, towards human clinical trials anticipated to commence in 2016.
P. aeruginosa infections account for the highest rate of mortality in cystic fibrosis patients, show a high degree of antibiotic resistance and have been historically difficult to treat. Earlier this year, AmpliPhi was granted a European patent covering various bacteriophage preparations for use in combination with antibiotics for the treatment of biofilm-related infections caused by P. aeruginosa.
"Frequent lung infections with high potential for antibiotic resistance are a common comorbidity in cystic fibrosis patients and represent a high unmet medical need with no optimal treatment," continued Mr. Salka. "These data further validate the potential of nebulized phage therapy as a new treatment option for more than 70,000 patients worldwide affected by this debilitating and life threatening disease".
I don't think that nsi-189 post did this. There have been many such posts on the different drug and neuro-stack boards in the past couple of years. Something is driving this increase - but I think its doubtful that the post in question is it.
I saw that post within the last couple of weeks. I dismiss it as not holding any meaning. 1 guy. No reporting of ruling out extraneous factors. No idea how long he has been using mood scale or if he did it retrospectively for this post (not valid then). He says 'we do know its a potent neurogenesis agent and hippocampus growth agent'. But we don't know that, yet. Unless he is mistakenly taking in vitro research and concluding its a known for in vivo human use. Unsupported info re SJW.Now he's going to start stacking - muddying his own ability to measure results even more. Nope. Meaningless post.
Thanks for providing friendly link C. I forgot about members only thing!
Most welcome lynx!
Kirk, his handpicking of this team, his personal and fund investments here - that and 004 are what originally lured me here too C. Then they brought Pimental and his patented IBS tx over and things got sweeter. Kirk's team are really proving themselves. Patience not my strong suit but I haven't lost it here yet. Don't plan to either.
Nice. Quintiles is a CRO - this guy will be able to make sure the pipeline studies are tight as hell. And he worked for FDA. Knows the inside ropes then. Very nice!
It's limbo until the ph2a cohort questions are answered. If answers conclusively rule out any increased risk, sp will rocket up. Until then, treading water. Could be a while.
Anyone who hasn't seen the slides of Voskhul's presentation at the annual MS conference, they can be found here: https://mscare.site-ym.com/?2015amslides Go to 'F', third bullet under and they'll come up. (Bedside to Bench to Bedside: Clinical Observations Driving Basic Research in MS (Rhonda Voskuhl, MD)). Nothing new for us here but validates premise behind both RRMS and the cognition trials.
Great post. Thank you!
We are talking about two different things. I am talking about the eligibility criteria trial description written by the researchers and CUR, submitted to and approved by the FDA, allowing the company to conduct the trial. Go to clinicaltrials.gov and read their ph2 trial criteria. This is what they used beginning to end. Any participant change during trial had to be FDA approved and would be found under 'changes' on the page. When we're talking about a trial and its criteria, generally it is this source we're referring to - the approved trial itself.
You are talking about the refinement of identifying target population characterisitics that is part of the phase 1 and 2 trial process and is used to create eligibility criteria for the phase 3 study.
Two different parts of the same goal.
And yes, they are refining the data now to further refine the characteristics unique to their responders and those unique to their nonresponders. They are working to be able to know the characteristics of who this will work on and who it might harm. You say "the criteria was mixed and rightly so". I think you mean the population was mixed, which, according to the study criteria, it was: "Subjects with sporadic or familial ALS, meeting the definition of laboratory-supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial Criteria (Appendix A)." That description creates opportunity for much inclusion. They also said subjects should be within 24 months of onset. But they didn't have to be or else they would have written that differently. They gave themselves a little wiggle room there. Go read the criteria for the study. Its important to get if at the source and to know it for every biotech you're in.
Refinement of the characteristics unique to responders, or, improved identification of target population, is indeed the work of early phase research(this is what you call 'finding the criteria'). With it, they will be able to successfully create the eligibility criteria for inclusion in later studies, creating a chance for a positive phase 3 outcome.
Well - he is nothing if not opportunistic.
The first page of her article and my recent post agree fully. Hard to see where you think one contradicts the other. There are no oppositional views between my post and the front page of her publication. Of course there won't be one treatment for all types. There may actually be multiple disease entities presently grouped under the umbrella of ALS. That's the problem for CUR. The factors that separate their responders from others may as yet be unidentified. Unique biomarkers are largely unknown in the neurodegerative disease family, but they are there, waiting for the technology to discover them to be refined.
FALS and sporadic ALS were approved eligible population of CUR's ph2a study - FYI. There is no reference in her first published page to ineligible participants having participated in the CUR trial.
Part of her article refers to drug trials, and she is putting forth a sound argument for a change in trial structure for this disease group, one that no longer looks towards a primary single endpoint. This is true and needed and will move the disease identification challenges forward.
Compared to what I've seen him do elsewhere - I just didn't think his piece was bad. This company's trials are too well constructed for him to do too much. Even without his piece - we would have sunk. Too many unanswered questions. Here's the thing about the trial - the patients in the trial all fit the trials criteria, otherwise they wouldn't have been there. CUR is still trying to identify what makes a responder a responder and a nonresponder a nonresponder - parsing out what is unique to each group suffering from this motor-neuron degenerative disease. That is their challenge for ongoing research. We know there are 2 major types of ALS but those 2 may have many subtypes as yet unidentified. CUR has to define clear subtype identification (and thus evidence-based exclusion) criteria. It's a very difficult challenge but if they are to move forward, they have to do it. They know that they have nonresponders and they may have a population harmed by the procedure. Since the ALS diagnosis contains what are likely numerous motor-neuron degenerative diseases, the identification work ahead of CUR is going to be extremely difficult.
Yes. He has really antagonized many companies. That isn't what's happened here though. He and many others called the company out on the data the company chose to release and the implications that info showed for the nonresponders. That's all. It was the partial results release and the unanswered questions of nonresponder pool that got the company into this situation. Full data release will get them out. People can try to blame him all they want but really CUR mismanaged this one and the onus is on them.
I know. This isn't NWBO though. Situations aren't similar.
I think people are giving AF way too much credit for this dip. We've been in news quiet. The ALS ph2A results were questionable in nonresponder population. More information needs to be provided before that ambiguity can be resolved. Investors don't like such grey area in any research study, so they sold. With no news to buoy sp, we continue decline. Much of this is natural to this sector during newsquiet. Combine that with the questions many need answered r/t the study results and we have an expected decline that is unrelated to AF.
Ya. I did too. IDRA consistently drops hard with news quiet. Long time pattern.
Thanks Citrati. This company has so much going on. They are going to be fun to watch over the next couple of years. Not an easy position as a long though - they ride up and down so sharply, so often. Trading around the core has let me keep my sanity here. In the long run, I know I'll be glad I stuck it out.
thank you C!
yes. I've been here for a while. bought too high (low 4s) Jan 2014. Was wise/lucky enough to sell a good amt in 6s - most likely have Citrati to thank for that. Used to IDRAs erratic behavior so really sell on peaks and rebuy in troughs now. Not worrisome as this stock sometimes moves dramatically for no perceivable reason. If they show drug activity in the marrow with their bone marrow aspirations (Wald trial), things will get pretty hot here. Risk, as always, but potential reward significant. Good luck to you too!
I bought some more today. IDRA's been boring the hell out of me for a long time but there will be a run-up to ph2 Waldenstrom results release in q4. May as well buy these dips. Erratic stock. Good science.