he said his knee feels great why would you suggest Hyalofast. Stay away from that if you can
I still maintain that statements from physicians in STRUT and STRIDE will be exceptionally valuable. Since STRIDE does not complete until early/mid-May, it will be some time. Perhaps a PR post-FDA meeting may contain an endorsement, but I don't expect it before early June.
You ask an important question: how many early-stage pharmas can have rolling submissions of BLA's. I'm not aware of reviews on this, so I cannot answer. Many companies: Alexion, Merck, Synageva, BMS, Novartis have had these in the past year, among others probably. There was NO mention of applying for accelerated approval at the CC.
Obviously, I can't give medical advise. If it were me, I'd look at all options, including Hyalofast, though any surgery is not a light decision. But I would discuss it with your physician.
At best it will be 2-3 months before they meet with FDA. AND........
It shouldn't just be analysis of the STRIDE data. It should be a FULL analysis of all data both SI and MI to thoroughly understand all trends and variables. Next cast a hypothesis on dosing regimen and patient variables. Next, if possible frame study/studies to validate hypothesis. Next run pivatol/pivatols. They don.t have the experience or judgment to frame such an analysis/program. THEY NEED HELP but don't know what they don't know......really scary territory. Burn rate and cash are driving their decisions at this point. I understand that, but it is OVERTIME to take a step back and re think the entire program.
Rushing to FDA with STRIDE analysis in hand and a half baked "next final" pivatol trial is just the same old same old. FDA are NOT consultants they are a regulatory body.
We have literally ONE peer reviewed publication on SPRING. The rest is top line sparse data on the drug. Thinking a big pharma DD team has vetted this and therefore we are good to go based on MMs comments is a bit of a stretch. This guy has been talking about deals for quite some time. And........DD teams are not always super thorough. We see deals that have been over valued all the time. Been there done that, where the scientific guys serve up an analysis and the BD guys dilute it and pay more or ignore it and make a bad deal.
Your knee is doing amazing not from saline my friend but from ampion. Your a subject that gives all ampio holders optimism that not only does this work and is well tolerated. We just dont know about the saline issue but will by the end of this. Forget your MRI if you knee feels good keep rolling with it.
I finally bailed out on AMPE after 3 years. Two failed Phase 3 trials and a management team that has over promised but NEVER delivered. It is a mickey mouse team.
If the next Phase 3 trial fails, they go Chapter 11 and stock zeros out. It is now uninvestable, I wouldn't be surprised if their 2 big shareholders - Act & Knoll - bailed out on Bloody Monday.
Them before the 24 week study ends. Patients and doctors are still Blinded and patients are still coming in for their week 24 end visit. Bill from your experience have you seen a company with data such as ours at this stage get to file for BLA while conducting another study . If the Fad takes 10 Months to approve the BLA why would they really care if BLA is filled with current data the drug works from all the data and its safe from all the data. The Drug especcialy works in KL4's that have no other options. Can one go further and ask why would FDA not approve Ampion with restricted label for KL3-KL4's now and subject to review of next study as it relates to additional label uses. I will tell you that again I spoke to a sports medicine Doctor in Scottsdale that does not think Saline, 3 shots of saline can give my bone on bone knee pain free status after 5 months
. I stand here and am so confused my knee is doing amazing and now the study says that it could be due to Saline. A few years ago I had my last knee scope surgery at the Mayo Hospital in Phoenix before that they gave me an MRI The Doctor agreed to do another scope but told me it's the last one nothing else he could do. If I have another MRI now is their value at all comparing this MRI to the one from a few years ago to see the difference?
allen, my frustration with this management is that they have an amazing ability to grab defeat from the jaws of victory. On Monday, they indicated that Ampion failed its primary endpoint. Obviously they know the numbers through 20 weeks. So, they should have given it. If the trial is a bust, why continue it? I'm really, really tired of the lame excuses, the lack of information (Optina was put on the back burner, but they buried it in the 10-Q) and the promises.
JD, some pretty accurate stuff but how can you reveal WOMAC when the study is still blinded? Bottom line is your assessment is understandable but there is still a glimmer of hope. IT looks like my call of a partner 2 years ago at a dec. shareholders meeting would have at least created some buzz for the stock. should be interesting to see how they proceed. Based on the burn rate at 1 million a month which is a lot of cash for small pharma, they will need a partner. I think if they do another raise this pig will be dissolved. Me thinks a big pharma will see potential and will get this dirt cheap. no sense in projections right now all hands on deck until FDA meeting and Guidance.
HA is marginally more effective than saline. HOWEVER, there are differences between the HA products.
Albert has very valid points. But, if 40's were achieved with KL3 and KL4, it is no worse, and probably better than current HA's. On that, I believe them. Why? Because there were talks at the valuation (ie, late-stage) which means a professional team has vetted the data (ex-STRIDE of course).
Might be. The final visit is near May 7 based on Apr 9 being the 20 wk endpoint. Analysis can be open ended, but the essential analysis of saline doesn't depend on that. The deciding factor is when will sufficient analysis be done. My guess is sooner, but maybe that's more hope than reality!
--- what were the WOMAC numbers for Ampion? that can't be revealed.
--- update on Optina? it's too complicated.
--- how much cash and what's the burn rate? $43 million ($7 million burned in Q1) and a $1 million per month 'non clinical trial' burn rate by the second half (so, another $7 million burn in Q2?); MM anticipates
another trial for Ampion, so why give the 'non clinical trial' rate? lipstick on a pig.
--- how much cash to Ampio on the Luoxis / Vyrix spin-out? zilch!!! so, how does that contribute to the long term health of Ampio? it doesn't.
--- why would anyone believe this management team? I don't
no dates will be given until the study is unblinded and they can dig into data. I disagree with bill on timeline. they wont get full data until end of may and will take a good amount of time to go over it. Depending on the FDA schedule it is my estimates that your looking in late June early July for a meeting. I am looking at 8/1 for phase 3 to begin with a number of studies conducted and a cash burn rate to leave us with just enough to pay the help.
I dont think the issue was the saline. Dr. Bar-or mentioned COX-inhibitors. It may be discovered that the obese population were taking COX-Inhibitors and it nullified the drug. The FDA can still accept the trial date but that is about a 30pct shot.
They did not. My guess is that they will have to wait for 24 wk data. So, assume at least 1 wk after that timepoint. That also allows time to analyze the saline samples and further analysis of cause/effect. Likely, mid-May at the earliest, late-May at the latest.
That is a key point. The fact that they were in late stage discussions with "substantial" upside for investors prior to STRIDE results (ie, $8) means that a pharma DD team has reviewed ALL data, including confidential data, and reported back positively to management.
Anyone who has ever been through one of these knows how exhaustive a DD team is. It is a very good sign.
the building is only an example how fool they are....and it's not a small issue, the $10MM can obtain the company more space for R&D investments, the building have no value for a start up company, the drugs is the issue. Sorry but you miss the point.
why play the what if game. there is enough material data to show efficacy. ampio has cash to do additional studies which are coming and frankly we will have more data to work with and more of an understanding. They can now structure the next study much better and produce both ampion and saline. The next study there will be no excuses it will will either go forward and a big prize at the end or the company will be force to shut down and dump whatever is left. Talk about risk. I will take it
there is some evidence that ampion works but how well it works is still rather vague, at this point i expect it would have to work significantly better than the competition in order to attract a partner or excite the stock market.