The only surprise is how truly incompetent management has turned out to be. EVERYTHING they said would happen hasn't.
The shorts had this pegged from the beginning. You continue to look like a fool.
I think Thursday will be simply an information session on the new trial. But I hope you're right. The new info on NSAID is interesting. I don't think it will parlay into Ampion for anything more than OAK yet but the market is big enough to make this sky rocket. I really think the potential outside of OAK is where this drug will find a massive market. Bigger than OAK is the digestive inflammatory diseases. While OAK is where it is focused right now, the asset could be worth a lot more for other medical needs. Especially considering Ampion is a naturally occurring substance. Or the morons will screw it all up. 50/50 shot.
OAK patients managing pain will be warned against the use of NSAIDS as pain relief and Ampion will look even better to those in pain. BTW the numbers in pain are in the MILLIONS.
copy paste and google:
FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes.
Of course, Ampion is not approved yet, but previous clinical trials including the patient numbers, the efficacy and the safety numbers are all there that meet the requirements for the FDA to allow Ampio to file the BLA for Ampion.
Expect BIG SURPRISE THIS THURSDAY!
Sentiment: Strong Buy
If you want to see what happens when really good visual gains are obtained, even without statistical significance, look at OHRP today.
AMD, DME, and other similar indications - all in concert with anti-VEGF's, and Topical administration via eye drops.
Great performance in AMPE the last few days, but not quite the explosion in OHRP today.
The problem with Ampio's trials is that they *don't* go smoothly. So, the FDA did not accept STRIDE as pivotal and we have to roll the dice again.
According to IR they are organizing another trial, so i'm assuming the results will be out if all goes smoothly at the end of the year, or early next year.
what interests me as to how effective ampion really is would be follow up results or feedback on patients that took part in prior trials. probably the feed back would be a lot more reliable in that the patient's feedback would be less likely to be clouded by emotion and very useful to know how long ampion really does supply a benefit.
think it would be useful to push management to supply that feedback at the CC, if they are not willing to do that i'd say it would be a bad sign.
Makes sense, but it also may mean that the BLA cannot start until they have delivered a 2nd "well-controlled" trial. At a minimum, single injection, 12wk endpoint like SPRING and they have to report yet another BLA filing delay.
Since no news release has been made we can assume no official decision has been provided by the FDA? Such a change in clinical status would seem to be a "material event" according to the SEC rules.
talked to IR yesterday, apparently there is another trial in the works. i asked what the meeting was going to cover, my impression was it was an update on timelines.
From what we have been told and can infer, they are planning another trial. I was told it was redesigned, whatever we wish to make of that. I'm guessing either randomization changes or more exclusion criteria.
What the FDA decides is another matter. If they showed causality for the saline deviation (per trial redesign), they may have a good argument. However, the statistics are not as good as Anika's Cingal (equivalent efficacy to Ampion with only SI), which met all primary and secondary endpoints. Yes, it was "only" KL1-3, comprising 90% of OAK patients. The agency doesn't take competitors into account for approval, but it does set a standard for expectations.
Other HA's have been approved with 1 trial not beating saline, but that was an exception and many years ago. New and better treatments are in testing now. They may have a higher standard.
Bill do you think they were instructed to do a phase 3? I think it is a real possibility but with all the statistical data to present and I am sure an overall good argument, common sense tells me that the board would have to take the info under advisement and review it and come to a consensus. Of course, this could be rather simple and they could analyze the arguments and simply say "You didnt meet your primary end point do another one" If that is the case then the CC is clearly going to outline the new protocol and perhaps try to mitigate another possible implosion?
I would not get to excited about 400k in volume. Just retracing like the overall markets. If you wake up and the ticker has a green arrow and a double digit number with a few commas in volume then get excited.
My thought was by the end of july we should have a very clear picture and yes doing your homework numbers wise is critical. The key component is that AMPION if proven successful has a great expansion into fingers, elbows, shoulders ect. and that is something else perhaps to consider. I feel that we wont get any real information from the CC unless of course they know they have to do an additional Phase 3 already and are preparing to launch shortly after the CC.
Allen, I'm in agreement with much of your comments. And, perhaps it doesn't matter short term. But, all of these competitors do matter in terms of Ampion value. I've been on similar assessment teams for big pharma and they spend a lot of effort doing competitive assessment; ie, what the real market share will be over 3-5 yrs (not the total OA market number that MM keeps throwing out).
Also, having the Sanofi's and Pfizer's and J&J's with investments already in the space means that they are already committed. J&J would be different since they prefer less R&D and more acquisition. In any case, price is based on discounted forward earnings estimates. The chance of Cingal being approved before Ampion is high. With a single injection it worked as well as 3 injections of Ampion. Follow-up injections were devoid of AEs. And, it worked for KL1-3. So, that is a threat, unless there is some data showing it worked less than it's avg 70% pain reduction in KL3's only. If Ampion is "first-choice" for just KL4's, fine, but that is only 10% of the total OA patient population.
I'm just saying it needs to be valued appropriately. But, most certainly, it should be valued much higher than it is today. From the FDA Site:
Possible topics at a pre-BLA:
To determine the adequacy of the sponsor’s dossier for an NDA/BLA submission
To agree on format and content
Early discussions on priority or standard review, and need for Advisory Committee meetings
Official minutes are issued within 30 days of the meeting. Also,
"during the pre-submission meeting the FDA and the applicant may reach agreement on submission of a limited number of application components not later than 30 calendar days after the submission of the original application."
Not a lot of volume today, but the stock is up about 12% on the day. Does someone know something the rest of us don't? Don't get me wrong it's good to see some buying come in
Its all guess work and our questions should be addressed at CC. I believe that they will get a BLA filing and run another phase on K4 patients. If that happens the great unknown is what is or is not on the table. I would have thought that as far along as they are with this study and data available, a pfizer or Safoni would have been aboard and maybe they were interested but the deal was not right. Many big pharma will pounce on this if a BLA awarded. OUT
Bill, These phases are to far behind and wont matter to us in the short run. My understanding is that AMPE management probably doesnt know yet what the FDA will propose. Looking at the process it appears that they usually will come back with a response within 60 days. I think the initial IND was 30? The CC is probably an update on litigation, Optima progression and a short briefing on ampion as it pertains to BLA filing. Going by your theory, when phase 2 study had the frozen blood issue they immediately advised the markets and started the new study. This time around they clearly presented or are going to present to FDA and then get direction for BLA/phase 3. If they were told no on BLA based on past actions the Phase 3 would be underway.
Just Phase I, but KL4 are included and Genzyme/Sanofi knows how to run a clinical trial.
Pfizer's OAK Phase II trial also includes KL4.
GZ389988, Single Injection