"From Dr Bar Or's recently published scientific paper - "We think that the findings presented
in this investigation, however, demonstrate that LMWF5A can..."
Looks like LMWF5A didn't work out as hoped for- no growth apparent. Do you think that Bar Or et al did experiments pre trials or chose to not do so in order to hype the possibility without being liable for, ahem, misdirection?
From Dr Bar Or's recently published scientific paper - "We think that the findings presented
in this investigation, however, demonstrate that LMWF5A can
alter stem cells function and that the proteomic changes in
the synovial fluid of patients receiving treatment indicate that
these observations translate, in part, in vivo. Consequently,
LMWF5A could prove to be a viable alternative to the existing
strategies for the treatment of OA of the knee"
Probably pointless, but most rational investors here know that there is no evidence of SC generation in vivo and furthermore, many SC therapies as well as OAK pain therapies are in process for end-stage patients as duly referenced in past posts.
Furthermore, Ampion is a T-cell based mechanism of action, as published by Bar Or several times.
As stated before, older HA compounds have been approved with similar efficacy issues, but Ampion clearly has not yet met the previous FDA guidance of proven efficacy with 2 "well controlled" and adequate trials.
The last news release on AMPION did reach an end point. Do you really believe that the FDA will not approve the filing of the BLA? It is given that Shorty wants you to sell your shares. As the shares drop in price who do you think is buying them? Shorty wants you to believe that AMPION does not work. FACT: No other drug company is working on trials for KL-4 Patients, Why, No drugs work, THIS BIOLOGIC WORKS. It generates stem cells so the body can rehabilitate it's self, read the last news release. They reached an end point.
The FDA will tell AMPE to file. Big pharma will have to cut a deal and "Shorty" will get fried. Of particular importance is the fact that well informed shareholder(s) believe that the FDA will prefer a filing on both drugs.
Optina data is great, it did reach an end point. More work will need to be done and big pharma will want to be involved for that next stage.
If you really want to believe Bill Williams, a know short mouth piece, you can give up; or read/trust the real news; not his #$%$.
Sentiment: Strong Buy
You are asking him to comment on your BS post within which you let your total ignorance shine through? Go away..
Yes, the fact that 2 independent samples were done in MI is also significant. The effects were slightly over 40% of SI, and given innate variation in the disease and scoring, that's likely to be real. We don't have the numbers to independently run the statistics though.
STRUT was only single site, so less variation in procedure would be expected. I've already noted that the statistics were weaker than what would be needed for immediate approval of sufficient data. The original FDA guidance was for 2 smaller trials rather than 1 larger one so they fully understand the consequences of that guidance on cohort analyses. The 20 wk SPRING KL3+KL4 was p=0.005 vs saline (-0.99 vs -0.65).
SI KL3 from spring was 73 Ampion and 66 Saline with p=0.04.
The KL3 from both SI and MI is what is impressive, but alone they are less interesting to look at.
"MI for KL3 is good".........Really......lets see.....N=59 for KL3s in Stride.....you think we can make that conclusion? Oh I know.....there were was a huge population of KL3 in Strut, I believe it was 12....so between the 2 studies.....we have a winner MI in KL3s......Really? You continue to reach. So......lets parse the data for KL3s from Stride......doesn't matter if the study failed to meet the primary endpoint.........run another study for MI KL3s.......combine the two and submit......wait a minute.....we can throw in the huge database from Strut on KL3 too......There you go.......no doubt FDA will approve that.... Very naïve. Less
If it refers to the news articles concerning Kimber's lab showing eSC full cartilage regeneration at 12wks, yes I am aware of it. Still experimental, but one of the best controlled experiments yet. That was in March, but similar studies at the clinical level are ongoing. SC for OA is clearly the future, probably within 3 yrs, but which companies will dominate is less clear.
..so well said. Unfortunately I learned a hard lesson investing in a highly speculative Biotech with a bogus management team with zero credible background or experience.
"MI for KL3 is good".........Really......lets see.....N=59 for KL3s in Stride.....you think we can make that conclusion? Oh I know.....there were was a huge population of KL3 in Strut, I believe it was 12....so between the 2 studies.....we have a winner MI in KL3s......Really? You continue to reach. So......lets parse the data for KL3s from Stride......doesn't matter if the study failed to meet the primary endpoint.........run another study for MI KL3s.......combine the two and submit......wait a minute.....we can throw in the huge database from Strut on KL3 too......There you go.......no doubt FDA will approve that.... Very naïve.
Couple things you can count on. Bookmark the post. In a couple of months it will become your new reality when FDA speaks.
1) Another study or studies will need to be executed.
2) There will be no form of expedited review. No basis and would have been granted by now.
3) No partner will surface. The data to date supports minimal value accompanied with efficacy questions.
4) The current team will attempt to design future studies. Frightening thought. They are 1 for 3 to date.
Your "analysis" makes far reaching conclusions. While cohort analysis is standard. Selective cohort analysis with insignificant power is not scientifically compelling. I believe it is called data mining. Trust me FDA will not be compelled by SELECTIVE cohort analysis with minimal power. Nor will they be compelled by pooling data from 3 trials (Spring, Strut and Stride). I am sure FDA will also factor in the team is 1 for 3 in pivatol Phase III trials. The best to hope for is Ampio conducts thorough analysis of the data and casts an achievable, pragmatic clinical plan moving forward. The clinical development to date has been a case study in development on the cheap conducted by a grossly inexperienced management team. Extremely risky combination.
And your analytical rationale is...?
It's fine to be skeptical, even short, but try to support your arguments with more supportive data and in depth analysis than adam feurstien.