It's likely, although the exact date of the FDA meeting was never provided. The holiday may also play a role in determining when the company issues a statement.
As previously stated, they could leverage this PR if they combine acknowledging the SPA letter with STRIDE physician comments. There have been no testimonials as was done with SPRING (and the early, open label, portion of STRUT). Although STRIDE failed to show improvement over saline, there may be individual success stories and/or ad hoc statements about Ampion's longer-term efficacy.
Actually, I'd prefer a joint announcement with a partner, but that's a lower probability event.
I know they make it difficult to believe, but they aren't fools. Conceited and inexperienced, but the "fact" (if we are to believe the MM statement about deal values pre-STRIDE failure) means that it's worth a lot more than current price. Even he admitted that offer was no longer valid. They are out of runway and will very likely not receive a premium. Probably a contingent/milestone based offer. But, even 20% less with a price greater than 3x of today would be fine with most. Mid-teens is still possible, based on comps, prior analyst estimates and progress in competitive therapies.
We've had these discussions before. I'm always looking at what can reasonably go wrong (since those don't get "promoted"). IMO, the Isolagen argument is not particularly relevant to the current investment opportunity, other than this management team has little credibility. That is not news.
What is relevant is that the FDA has declared 1 Ampion trial pivotal and is willing to state in writing that only another demonstration of efficacy in a similar/identical(I hope not - too many K2's) will be sufficient for a BLA. This is better than 2 years ago when the guidance was for just 2 "adequate and well-controlled" studies to measure effect size as *Necessary, but not necessarily sufficient* for a BLA. While it is possible MM lied about late-stage partner negotiations, it is not likely. Plus, clinical physicians have publicly verified Ampion's efficacy.
Therefore, IMO, the positives outweigh the negatives. But, not everyone invests this way. I'm sure a big investor that lost in Isolagen is one of the major shorts here. Nothing wrong with shorts - they tend to dig deeper than most longs. But, they are not always right.
The one item that I can agree with is that MM is a "promoter" (id est, "hypster") and is guilty of overstating company assets and opportunities, while ignoring risks and failures. So does every Politician and nearly every CEO. It is up to a rational investor to see through the BS.
I seriously doubt they are lying about the interest of a partner in Ampion. That's one rational investor that has seen through the smokescreen and see's value (but the check isn't written yet). Luoxis is also real, though much lower value and longer time horizon, as is Optina. Zertane has no value and the rest of the "pipeline" touted in early filings and presentations is a pipedream.
There are plenty of examples of companies with effective compounds that have gone bankrupt before getting them approved and effectively marketed. AMPE is running out of runway and they know it.
The numbers are not high either. Therefore, a few nickels of movement cause large percentage changes. Professional traders take advantage of that.
Attributing a cause for moving up or down against general market is mostly just wild speculation. The only thing we know for certain is that the SPA will be received soon and at some point after another trial will start.
In this climate, that news is no longer new so the stock may not react at all.
The majority of longs are Institutional Investors. Historically, many gave up after STEP failed & many others after STRIDE failed. Additional II's have assumed some of the shares, but at lower percentage each, though Knoll has stayed the course.
I doubt Knoll would sell at $5. There is value in Ampion (perhaps 2-3x $5, depending on Ampion final results and the Q4 results of near-term competitive therapies). Whether the current team can finally provide the necessary and sufficient data is another matter. For novices, they've done well. But that doesn't get an approval or a lucrative partnership/buyout. The market also plays a role in the premium someone is willing to pay for assets. That just got a lot lower.
It'd be nice if it performed as well on strong market days.
Down 9% currently with typical avg vol. Probably continued trading, not strong demand or strong selling.
We "hope" it will at least start fluctuating at higher levels on the SPA news due soon.
agreed re:Phase III AMD. They continue to "postpone" the Elman final results. It's not "less relevant". It means that it is not a panacea for PDR or any other retinal condition. But, it does have multiple indications of benefits. They just need to survive long enough to prove it statistically and then effectively partner it. But, they appear very slow on starting the trials. It may be difficult to recruit with other AMD trials concurrently.
good luck with that. Since it's already a major holding and hasn't performed according to expectation (twice), I can't justify yet more risk. But everyone's situation is different and it's certainly a better buy here than it was on the last secondary or on any of the pre-results run-ups.
So long as people don't get too excited over a stock that has 300% to go just to get back to the same price it was before announcing the failure of STRIDE. After all the disappointments, we should not forget what we are dealing with here: high-risk/high-reward, inexperienced managers and a difficult threshold to beat convincingly.
But, for those that think we will cycle back to those numbers before the end of the next trial, it does seem like it is bouncing along the bottom. They just need to understand the potential downside as well. This can go to less than $1 if the next trial fails again.
If I didn't already own more than I should, might even buy more just because it can be a trading vehicle on just anticipation.
exactly. Reporting overdue Ellman's IST wouldn't hurt either, unless the other patients didn't improve. One thing hasn't changed with the new leadership: communication with investors is still lousy. They could at least update the status of Phase III trial design and explain why it is taking so long to launch. Or, discussions could be going on in the background for a deal. Without information, uncertainty is high and it deserves it's current price.
It's risk-off again so that lowers valuations, but a year from now, will it matter? Especially if the world economy begins to improve. By next August the chances are good that CPRX is much higher than today, based on what we currently know. I didn't panic at $1.50 and I'm not panicking now.
Has anyone been following changes in 13F's? There are substantial stakes by several private firms. Other than Baker Brothers, Point72, Broadfin do Consonance and Federated have an established success record with biotech?
Good luck with it. You have been a rational voice for a long time together with several others like budda/TH3. Very few of those posters left.
Still think we have a shot at much higher from here, even before the next/final trial results. But then, the yo-yo's will start in about 100% moves from the recent $2.
it's not Ampe-specific. Most all biotechs are holding up fine today. Lesser quality was sold earlier, gains were taken in others. I have one good co. (met their Phase III endpoints) that was down 10% yesterday and up today. So, we bounce along the bottom and hope for upside on SPA receipt. Agree with others though, it's likely not to do too much until near end of study unless something surprising happens, like a partnership.
(Yahoo clips less than signs... BTW, p LT 0.0001 means 99.9999% chance the result is true - Unlike STRUT to STRIDE supposedly great number of 96%)
LT 0.0001) acute changes in blood measurements of an established neuroendocrine biomarker.
The multiple ascending dose study, which used repeat dose studies of the 0.1 mg, 1 mg and 5 mg tablets, administered twice a day (b.i.d.) for one week, demonstrated that all tablet doses were well tolerated with no serious adverse events (SAEs) reported and all adverse events (AEs) were mild and generally similar to those reported with I.V. CR845. Additionally, clinical safety laboratory measurements were normal across all tablet strengths after single or repeat dosing."
Actually, it is NOT ASE's, as I pointed out in the OP. Even a cursory read of Phase I data shows that (below). Cara is Derisking the trial, which is smart. Ampio should do the same.
I've already stated all the risks with the next Ampion trial, beyond unknown risks such as with STEP. Obviously, that problem will not occur again. But the less-experienced investors here should now be aware that unpredictable issues will cause Failure. They might even recall the nonsense spread here from MM's statement that STRIDE will reproduce STRUT efficacy with 96% probability. That is just too low. We just need to see what numbers of KL2's are and what restrictions they put on KL4's to get a better estimate of success.
"The double-blind, randomized, placebo-controlled trial evaluated the pharmacokinetic and safety profile of single and multiple escalating doses of Oral CR845 in 150 healthy volunteers at a single U.S. site. The single ascending dose study, which included six tablet strengths ranging from 0.1 mg to 10 mg, demonstrated a mean oral bioavailability of 10% across all dose groups under fasting conditions, with a range of maximum plasma concentrations of CR845 bracketing the concentrations seen in previously successful Phase 2 trials with I.V. CR845. All tested dose strengths were also shown to be active at the kappa opioid receptor, as assessed by statistically significant (p
Cara's oral CR845 started Phase II dosing for osteoarthritis (OA) of the hip or knee. No exclusion of KL4's, but it's interesting to note the exclusions based on bloodwork. Peptides aren't hepatotoxic so it's interesting to see items such as ALT and AST included. They appear to be ruling out patients with other systemic issues that might affect a subjective pain measurement. Smart. The intent is to replace opioids, so this is different from the inflammation reduction MOA of Ampion. Readout ca. 60d from last dosing.
actually, nice setup for other structure-based design stories. PLP is used as a cofactor in multiple systems.
It remains the key question. They have not updated the clinicaltrials site or otherwise elucidated the protocol change. But, Phase 1b is placebo controlled and it is possible that they wanted to maintain that masking rather than repeat a recruitment and randomization from scratch.
VC stated "45 days to reduce to writing". That is verbatim. What is not known is the exact date of the meeting, but early July is reasonable. So, the exact timeline cannot be determined. As stated previously, having it by the end of Aug is a reasonable estimate.
It is "less than 60 days to the start of the trial" - I didn't catch whether it was MM or VC answering that specific question.