Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Nice pumping
They basically just a PR out targeting the points I have been raising. Why not say this the first time? They went to the forums and saw the discussion and did a PR to try and compensate.
And the primary endpoint which was a DIRECT measure of severity, showed no signal. Again, this comes back to my point about digging around in the data to find some significance. The primary was negative.
He needs to use a legit media source. Speaking on the biopub who are on the board is a massive conflict of interest
What concerns me is why hasn’t William shown his face
That’s absolutely incorrect. they did not find it reduced the severity. They specifically said the primary endpoint showed no change compared to placebo meaning they failed regarding severity. They said the duration might be less but wouldn’t know without more data which we are only getting from phase 3 because they increased the number of patients in the interim data set to manipulate the numbers and try to find signall. The more promise finding I was happy about was reducing time to ventilation but again, this will only come from phase 3
If they get approval for phase 3
I'm frustrated.
Every time things seem like they are turning a corner and we have something legitimate here, there has to be a catch. These guys shouldn't F around and play with the numbers. Either say it's negative or say it's positive and move on. I wouldn't fault them for negative data, in fact I would be happy they gave the trial a shot and kudos for orchestrating something major. I would watch my temporary gains dissapear but remain confident long because we have another chance with IPF. However, don't play games with the plan. That makes me question.
Despite the aforementioned frustration, it is of utmost important that these conversations occur now.
Will the timeline for chronic cough be met... no idea. Won't pretend to know. I would guess maybe.
Now that I have voice these frustrations I am probably going to step away from this while it drops back to the teens because I will get too frustrated on here!!!
See my last post. I think the only issue doc williams made was choosing the primary endpoint they did. I mean, they even came out and said after the release, "we didn't really expect to find a change here for this endpoint"... well.. that is inherently an issue.
I think whoever did the data analysis (e.g. australian contractors?) have increased the sample on the interim analysis and thats problematic. You cant change your plan like that unless your trying to hide something.
They deserve credit for giving this a shot, no doubt. But don't manipulate the plan. It is indeed shady behaviour. They have shown us the almost full data but did so by increasing the sample to find signal.
If this type of change of the plan occurs in real scientific studies, they are disregarded and don't get published, or they have to state it as a limitation because of the potential for post hoc data manipulation.
The issue here lies in the potential for data manipulation. I have been saying this LONG before the news release - this trial was not POWERED to detect a statistically significant change in some of the endpoints they are claiming to see a trend in. What matters most is the endpoints they chose as primary. That is what they used to determine the needed sample size (number of patients) to find signal. They found no signal for this endpoint. They came out and said well we didn't really expect to find change for this endpoint. WELL THEN WHY THE F DID YOU SELECT IT AS THE PRIMARY ENDPOINT. This is the reason the market freaked out. Because saying "well yes but we found another endpoint that might work" isn't how it works. Any signal in these other endpoints can be due to random chance because of the super small sample size numbers. Power relates to the number of patients that are needed to find the signal in a statistically signficant fashion and rule out that its not due to random chance. The fact they increased the sample on which they were doing interim data report from 73 to 120's is VERY problematic as it is very suggestive of post hoc data manipulation and these findings are just due to random chance. Hence the market reaction.
With this said, there is still hope that Phase 3 might find signal for time to ventilation... it's just not as clear cut as we would have hoped for because of all of these aforementioned variables we must now consider.
I hope the IPF and chronic cough data is better.
The error here is your hypothetical scenario. Statistically we don't have those numbers, which means that with super small "n" values (probably less than 8 in each of those arms pertaining to time to recover from ventilator), any finding can be due to random chance in the absence of the statistical power we need which would be derived in a larger trial. Which is why I am saying we need phase 3.
The problem here is this sort of data mining represents post-hoc analysis and is not held in the same regard as finding signal in primary endpoint
I agree, there are positive signs in the data. The company has disclosed that in lay terms. However, increasing the number of patients in the analysis in order to find a trend is concerning. Regardless of whether the data is good or not, my point here is that the stock market has reacted negatively and that we don't have anything else to look forward to a while so we are in for a bumpy ride.
I think the conversation here has been pretty leveled thus far. There have been times when we all get hyped up, and certainly before the news was one of them. I mean rightly so, we have been waiting for that glorious moment for a long time. It's a bit of a let down.
If you are riding the rollercoaster of the stock, be prepared for it to drop over the xmas holidays and into the new year. Particularly because the next data set is only adding a few extra patients, the market has already responded.
If you are long, then probably the next glorious moment of opportunity appears to be chronic cough study results.
The final data set won't contain anything else. They just released data on 123 patients. Do you know why they did that instead of 73? Because clearly they found no effect at 73 patients so they analyzed more in order to increase the statistical power to try and find a trend. That is concerning. That is why I think this is dropping. It's a bit like data mining. You really don't want to see a company need to look furhter to find the change they need to prevent the stock from dropping ... The only glimmer of hope is that the PHASE 3 will still go ahead and amass enough patients to turn a trend into statistical significance. The "final" data set only will contain an extra 20 patients...
It’s clear the market has decided this is heading back down. Unfortunate for sure. We don’t have any news until the new year so buckle up. Weak hands about to be shook.
The sister company has never made sense to me. Sustains rises in stock price with absolutely ZERO proof of any legitimate material goods, just pure pump over the course of nearly a decade. Meanwhile, AGN here has a positive clinical trial for covid and drops 30%. Explain that.
Abuse from them? They announced they have a positive signal. They also said that the drug reduces time on ventilator. To me that's a big deal. The market reaction today doesn't matter if you are long. Just my opinion but today was what I expected in terms of news. The market reaction is a different story but this is penny land.
Why is a dark cloud rolling overhead? The results were good? Just because the stock market had a non-sensical reaction with many stops triggered within seconds and pumpers bailing when it didn't sky rocket, that doesn't change the fact the results are good and it's going forward to Phase 3
The most important things for determining if moving to Phase 3 ... is it safe? Is it effective? What should the primary endpoint be?
1) Yes it is safe
2) Yes, it is effective in decreasing time to ventilation and possibly leads to faster recovery
3) ^ those should be the endpoints
The stock market is full of people who don't understand what's being reported. This will bounce back because its a poorly worded news release on good results.
That would be odd though because everyone expected/anticipated that we would have to wait because that's been the plan all along. We never thought today would be final results.
This is ridiculous. The company released good news. The halt made sense. The market reaction was BS and makes no sense. Weak hands all hoping for a huge instant score. Show me other companies with positive phase 2 covid data. The SP should have went up (as it did right at the time of market open) before all the stops triggered.
Why wouldn't he show is face. He did nothing wrong. In fact, HE RELEASED POSITIVE DATA. The drop in SP doesn't even make sense.
The number of weak hands that had stops triggered ... the SP dropped within seconds
The news release is good. End of story. If this reduces time to ventilator and hospitalization time, this can be a top 3 covid therapeutic, simple.
They will. This is huge. Means we are going to Phase 3. Time to ventilation to become primary endpoint for the phase 3 trial. So awesome. This small underpowered trial served it's exact purpose of letting us know if phase 3 is worth it, where we will have enough patients to know if this reduces time in hospital and time to ventilation. They will be in talks with big pharma for sure.
JACKPOT
Moment of truth, LETS GO
Good luck this week to all!
Like they said, this is the monumental inflection point
All truths shall be revealed
It's hard to believe they have come as far as they have in such a short period of time. Incredible really. Immense amount of work and regardless of the outcome they should be commended.
Compare regarding mechanism or compare regarding efficacy? Because the latter has yet to be established but we will know next week.
Two PhD's, that's unfortunate!
I don't need reminding of the failure rate of pharmaceuticals moving from animal to human studies, having worked in drug design myself. I agree. Here. However, we have a safe medication which has positive data and as far as I am concerned, this is the best thing we could ask for. The rest remains to be determined by fate.
I have a lot of faith in the Chronic Cough trial we are running, because our own Scientific Officer did the animal studies showing it works
We will know within a week (or so)
Nice catch: Lets analyze this...
A few points to consider when determining future SP:
Many are already drawing comparisons here to Rem. Ok, the first thing to consider is the efficacy of Rem. Not great. Largely, the price of the stock and the valuation placed on ifenprodil will depend on the efficacy. Aka, how much signal. How much POSITIVE signal specifically. Again, these concepts become abstract but generally, there will be a big difference between a drug that has a 10% versus a 40% reduction in the number of patients progressing to ventilation or acute lung injury or mortality rates.
Second, the price of the drug and the trouble to make it. Immunotherapies are pricey on the market, largely because they are complex and hard to synthesize in mass. Ifenprodil is not a complex organic chemical compound, it's chemical features are basic. That means probably, less costs to produce and hopefully more profit for the company without having to charge as much on the market. So this goes to show, market price doesn't correlated with profit, because you much factor in cost of production. To summarize one more time... cheap production cost = more profit per given market price.
The points brought to light by Chris in his recent memo to the mailing list are valid. Skepticism around vaccine use, lack of supply, and ongoing scientific testing/safety monitoring mean that a treatment for COVID-19 is needed (not just a preventative therapy like a vaccine).
To further clarify, CM will not personally analyze the data. They will have a statistician analyze the data. But perhaps you can help clarify something for me... why is the share price only 40 when the price hit 50 based on the thought of doing a trial, yet now we are completing part of the trial!
Suppose it would be nice if share price rises pre data release but ultimately doesn't matter... whether it goes up or down now... the data release will send it flying in either direction.
Their idiopathic pulmonary fibrosis trial is ticking away in the background and is going to be another winner
All we need is positive Phase 2 and this will be a rocket ship. I mean Phase 3 is largely about safety and we have already unanimously had safety approval at each check point. Plus this drug is repurposed and has a known safety track record, which eliminates A LOT of risk. Essentially if you have positive signal this will immediately trigger big pharma interest. It would also surely help with fast tracking FDA approval.
Brief overview of what each stage of a clinical trial is meant for