Astra Zeneca today is proof of that. Thankfully, I put my money on Relypsa. I've started charting companies and how/what catalysts cause biotech to move in the market and in what time frame.
This one has me worried since I still have a pretty penny in it and it has inexplicably stalled.
There goes BS Bill Williams going off at the mouth just like Old Faithful. This guys is in deep trouble with the FBI and he hasn't figured it out yet.
BEWARE OF BS BILL WILLIAMS!!!!
Sentiment: Strong Buy
I have over 20 years in pharma R&D- both big co. and startups. Even the big co. get it wrong for reasons that are unknown and unpredictable. This is high risk/high reward, especially with minimal cash left. I invested after SPRING thinking STEP success was easy based on statistics and balance-of-evidence. This can go to $1 or $10 in a single day and it doesn't matter if the drug works. The trial has to work.
I am in pharmacy school at a top, research heavy school with a few friends who have graduated into various industries who have expressed in interest in this situation. It's very peculiar. It's too bad I sank a lot of money into this and had to learn the hard way about how to properly invest in biotech.
I can really recommend reading the forbes article. Google "why too many clinical trials fail". The issues with requiring a minimum p value of 0.05 is discussed in non-science terms. There isn't a new adoption of more stringent standards, but p values of that magnitude are poor predictors of future success. What I was saying in the response was SPRING p=0.004 PLUS achieving a secondary endpoint PLUS repeated efficacy in STRIDE supports the True Hypothosis that there is a biological effect (not just a statistical difference, aka p value).
Still don't understand why saline had efficacy up to 60% since they said they didn't have any explanation that was statistically valid. However, they certainly are trying their best. But, it is an active placebo and new trial problems arise all the time. It's rarely the last problem that's an issue with the next trial.
The paper for SPRING is in PLoS One. It's freely available so please do have your pharmaceutical colleagues read it.
Did they adopt the newer, standard scientific p-value of 0.05 in this trial and/or take further steps to minimize the saline from being skewing results?
I really wish clinicaltrials.gov had papers I could read so I could tear the last trial and new trial with my pharmacy friends.
I'm in a similar situation though added in low 3's for the usual run-up. I have so much (over 100K shares) I may take some off to be safe. Getting killed from STEP, STRIDE and early termination of STRUT have made me rather conservative. So, to be conservative, the weaker position (market, cash, expectations) may mean that the price won't move all that much from 4's. But history shows it can indeed move up fast.
Agree about general timeline, though based on past announcements from enrollment end PRs, early July is also possible.
The supporting data for trial outcome I was referring to was for the STRIDE trial. We had data from the STRUT trial (also 3-injection) that was good, although very limited (20 patients/arm) released before STRIDE ended. As it turned out, STRUT was not predictive of STRIDE.
SPA letter removes regulatory risk. It does not remove trial risk. All the letter states is that IF certain trial conditions are met (specific power, p-value, efficacy relative to saline, demographics, etc....) the agency will ask for no further clinical trials in order to review the BLA.
I do believe the drug to work or I would have sold long ago. SPRING, STRUT and even STRIDE (if saline had behaved "normally" are independent tests of the hypothosis. The only one with enough "power" and significance (p value) for BLA review is SPRING.
p-values are over-rated (see Forbes "why drug trials fail"). Having p-values lt 0.001 AND secondary endpoints met are necessary to have high confidence. p=0.05 is actually poor. We have an active placebo, p=0.004 for SPRING and a few 2ndaries met (FDA: "robust"). But we know it did not work better than saline on KL2's, hurting results. The SPA required KL2's to be the same as SPRING. So, there is risk.
It seems possible there will be some run up/pump in the next few weeks. The run before the last phase 3 happened roughly one month before the announcement. We know the results will be announced at earliest in mid June and at latest June 30th -- correct me if wrong.
One thing I question about what you said was there was supporting data for a good outcome. Do you not believe the drug is efficacious and an SPA guidance provides a better theoretical chance of passing?
I am at a $5.15 average so I may just say YOLO and not take any money off the table right now.
Look at a 2yr chart instead. Near term fluctuations may just be traders, not fund selling or ATM tapping.
We are roughly 1/2 of where we were pre-STRIDE results. The cash position was much stronger then, there was data from STRUT supporting a chance for a good outcome and the general market was stronger (including biotech). Those conditions no longer exist, so perhaps it doesn't run up much further.
wow NERV and FLXN .......yesterday AMPIO Volume: 104,453 vs Avg Vol (3m): 211,551 ..In italy we tell "UNA VERA SCHIFEZZA"
Lately we saw some small cap stocks skyrocket such as: NERV FLXN CPXX TTNP. We believe that AMPION (AMPE) team is working hard to produce the same results. Hope for the best for our long term investment in AMPION!
Sentiment: Strong Buy
Yeah I agree with that. These MB's are for people to voice their opinion. I'm not on the fence on William Williams but certainly not supportive of that type of blasphemy. Retract that if you don't have proof of such.
People resort to HA or steroids because they are in pain and even slight relief is better than doing nothing. Until Ampion is in the market there is really nothing to provide meaningful short or long term relief without significant side effects.
I believe when Ampion is approved it will be the only efficacious and safest therapy for the patients most in need.
Bill Williams used to post about herbal remedies as well as other substances as competition to Ampion. That’s what earned him the nickname “Ben Gay”. Not surprising since the goal of his more than 3,000 posts is to cast doubt on the value of Ampion and AMPE all in support of the shorts who pay him to salt social media with his authoritative sounding yet intentionally misleading and negatively nuanced posts.
Now he suggests that yet to be approved drugs which are combinations of HA and steroids are going to be meaningful drugs in the OA marketplace. Bill knows HA doesn’t work well. It is still being sold only because there is nothing else on the market that does work without significant side effects, i.e. nsaids and steroids. And even those two do nothing to help the most severely afflicted patients-KL4s.
The American Academy of Orthopaedic Surgeons could not recommend using HA for knee OA. Various insurers no longer reimburse for its use.
Combing the HA with steroids doesn’t eliminate the reasons why physicians have turned to steroids to treat OA only sparingly. The side effects, particularly of extended use, are significant and unacceptable for most treating physicians. I challenge anyone to ask an orthopedic surgeon, as I have with many, if they would consider long term steroid use, slow release or not, for a patient with severe knee OA.
Their answers are a resounding no. If these patients ultimately need knee replacement, which unfortunately many do, the steroids can make that impossible due to joint tissue damage associated with steroid use in the knee.
In that event the patient is left without any options to alleviate severe pain.
Furthermore even Bill concedes that steroids don’t work for the KL-4s, a huge unserved market.
really? please reveal those facts as to how you know he is under SEC investigation? If you can't/won't do that,m please retract your statement. I'm on the fence on Bill - but we all have the right to see the support for your serious allegations.
Billwilliams is OBVIOUSLY paid by the hedge funds that are shorting AMPE. He has posted consistently with remarks to make the reader believe he knows what he's talking about, but the bottom line is the same every time.....he always has something negative to say and always creates doubt.
I know for a fact that he is under investigation and the SEC is watching him very closely as well as the hedge funds that pay him to hold the price down.
This is not going to end well for him.
Sentiment: Strong Buy