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That's what I was thinking? the EMA submission was the bread and butter of keeping this thing afloat.
Yes but there's a reason for it. Emricasan works as it was shown to have an antifibrotic effect. the reason the trial failed was because the 3 patients in the F6 group had a 100% response rate.
There's a reason for that. The problem and why it was bad luck is that when you do a liver biopsy its taken randomly off one portion of the liver. So when you use the drug it could have helped one portion of the liver, and the portion that was removed was still bad.
In any case, if you take out those 3 F6 very sick patients, the trial would have passed. Understand that the results were still good. It proved in essence that emricasan has an antifibrotic effect in fibrosis/cirrhosis which many NASH companies can't say.
Anyways now I now that the next study is going to meet its primary endpoint, because of how well it performed in the POLT-HCV trial. Hope that makes sense.
I would just keep accumulating shares. The biggest problem is the OTC market. If they uplisted to NASDAQ I guarantee you funds would have already poured in. The problem is that they can't invest in companies that trade on the OTC. An uplist with a reverse/split needs to happen to get this stock higher. Until then it will trade in a range
In essence if the ENCORE-PH meets the primary endpoint with stat sig, and the data is really good then Conatus can move straight to filing for FDA approval on an accelerated approval basis. That's because the FDA has stated that HVPG acts as a surrogate endpoint (meaning there is a clear biomarker that shows efficacy of the drug early on).
From there, the FDA would approve emricasan after phase 2 when it files the NDA, and it could run a phase 3 after FDA approval. So in essence the FDA would approve the drug and then conatus still would run a phase 3 anyways. But it would get emricasan for NASH cirrhosis patients with portal hypertension approved early.
That means if the primary endpoint HVPG hits, the stock will explode upwards.
Considering a lot of the data has to be kept blocked until presentation it's hard to tell how good it is.
Well duh, further study means moving on to the next stage of clinical testing. If the data was bad, they wouldn't list that.
Abstract is Up
https://meetinglibrary.asco.org/record/161877/abstract
In this population of heavily pretreated mCRPC pts ADXS-PSA + pembro had a manageable safety profile and showed promising activity compared to monotherapy. These preliminary data warrant further study. Clinical trial information: NCT02325557
So what I see is that the results are good, it generated a host of stable disease. Remember these are heavily pre-treated patients who don't respond to other therapies. Plus the combo ended up being better than mono alone.
That means prostate cancer data is approaching combo with Merck's Keytruda..........boom it's gonna be huge
The phase 2 prostate cancer results will be important. That's advaxis tech with Merck's Keytruda. if the combo proves to be successful I can guarantee the stock price will head over $5 per share. As for the EU decision yes the stock may or may not run into that. But if it does get approved it will definitely be huge.
After CC I see that once the results for the phase 2 ENCORE-PH are out, if it hits the primary endpoint of HVPG Conatus can file for accelerated approval. that means no phase 3 needed for approval, only post approval.
Acadia Plunges On Single Report, But The Drop Was Not Justified
https://seekingalpha.com/article/4161970-acadia-plunges-single-report-drop-justified
Remove the "7" lmao and that's the new number "0"
Stay strong it will reverse. The news was good, it's just that those headline traders are exiting. need long-term holders to buy and bring it higher.
correct, these were the first ever results. No other drug has ever been tested in this indication. if not for the 3 F6 patients the title of the PR would have read " Phase 2b Primary endpoint met". People are only looking at the headline and not the entire picture. That's where you take advantage. I can't believe all this selling. they were the first to prove anti-fibrotic effect with emricasan in this patient population. I see Novartis as pressing on to a phase 3 study for sure. F3 through F5 was 95% response (19 out of 20) patients in a severely sick population. No other drug does that, and it's safe. Novartis will push this to a phase 3 for sure.
yah it is this study, that's true!
https://clinicaltrials.gov/ct2/show/NCT03479125?term=conatus&recrs=abdfm&rank=3
That' or they could have just initiated a partnership trial to study the combination of ermricasan and Novarti's FXR agonist.
Yes hopefully we hear something soon. With the finish date of the phase 2b in March, I hope the company releases the data in April. preferably if possible by the time EASL takes place in 2 weeks.
I think it should be cleared up soon. durvulumab has 1% chance to cause respiratory failures observed in other trials. once this is cleared up the hold will be lifted and Advaxis will be fine. It's the clinical hold that's hurting it right now.
It will be sometime in April no where in May or June. The reason being is because of the clinicaltrials website listing read the completion dates:
https://clinicaltrials.gov/ct2/show/NCT02138253?term=conatus&recrs=ad&rank=2
Says estimated completion date of March 2018
yep I hope people read this stuff and steer clear of this failing company. Honestly though, I'm surprised the board of directors haven't fired Geert by now. Any other company would have canned him a long time ago.
Yep now they said the data wasn't available for 1501 or 1502 because of strict FDA regulations......I call bs on that. I believe they didn't release data because they are gearing up to raise cash in the coming weeks.
As far dangling a carrot yep, they have been doing this for years. Now they won't enter the clinic for the cancer pre-clinical pipeline until 12 to 18 months from now. What do investors have to look forward too? More dilution and reverse splits until then. For those reading this forum I would avoid RXII at all costs. Better biotechs to invest into out there.
yes Gestalt as I stated many times on here already, a reverse split is necessary to get away from this toxic spiral of bounce. The problem is that not many big institutions can buy shares on the OTC. It has to be done, otherwise this won't go nowhere even with the filing of the BLA for Pro 140 as a combo therapy
Who else is excited about the upcoming POLT-HCV-SVR data? I hope emricasan does well to help the patients.
yes, can't say i blame them. The most avid supporter was Broadfin capital but they lost out big time.They were big time owners of this, but I dont' blame them. RXII duped them and all of us
Exactly right BlackDoggie. But the point is that every other biotech and comapny that I have seen do a r/s are still stuck in a phase 1 or phase 2 studies. That have not even reported phase 2 yet. RXII was one and that was a disaster.
You can't view CYDY in the same light as all other reverse splits because those companies didn't have anything of value. CYDY has just met the primary endpoint of a phase 3 HIV study that is huge. I believe that once a reverse split is done it will give institutions a chance to buy in.
NASDAQ only needs $4 per share for the NASDAQ capital market, NYSE only needs $2 per share. Neither exchange requires $5 per share for uplist.
R/s is needed. Look at all the good news that has come. With all the good news, especially the phase 3 combo data for HIV should have put us at least at $2 per share. the OTC is built on NITE and CANT shorting stocks and manipulating share price.
Most other biotechs that did a r/s were not this far along. They were only in phase 1 or phase 2 that I have seen in the past. LJPC uplisted when it was only in a phase 2. The thing is that Cytodyn has already passed a phase 3 combo for HIV that's huge. I think as soon as it gets on the NASDAQ institutions may buy in. It has to happen otherwise not even BLA news is going to move the stock on the OTC.
A reverse split at this point is necessary. Even after announcing positive phase 3 combination data for HIV this still is trading with a market cap of only $131 million. It should be at or above $500 million market cap right now. A reverse split is needed for sure. OTC has too much flipping and manipulation going on.
If result meet primary endpoint and above average then you will be seeing at least $20 per share or higher
Well, the POLT trial had an interim analysis done by an IDMC and recommended the trial to completion back in 2015. They got to see initial results of mechanism of action.
http://ir.conatuspharma.com/news-releases/news-release-details/conatus-announces-initial-baseline-data-phase-2b-polt-hcv-svr
Correct, but they are both being measured from baseline.
first for dilution for sure, but yah after that more than likely r/s again. RXII is a total disaster the whole management team has to go
I can kind of agree with that. the only reason why is because this is the only study that was open label. Meaning that an interim analysis could be done by an IDMC. However, I don't believe that management was privy to results. But at the same time investigators do probably get feedback from patients on whether a treatment is working or not. In that sense, you can't assume that the placebo is the drug that is working well.
Having said that what I think will happen is that the primary endpoint will be met. However, worst case scenario is that the primary endpoint will be close. Comapny has stated that anything above 5% improvement compared to placebo will warrant further investigation. However anything below 5% will be bad.
From what I have seen with the ad hoc data after only 3 months of treatment of emricasan and being able to improve compared to placebo with stat sig, means that the results for the POLT trial should be good. Good luck to us all who are holding.
This run up is definitely product of LPC. I expect an S-3 form today around 6 p.m. time or early Monday morning. The company only has $2 mil of cash left in the bank maybe.
That's true, they could have done so much better. For me I didn't see the writing on the wall early enough. I will admit that the Samcyprone purchase didn't spook me when it should have. An RNAi company buying a non-RNAi asset? Yah hindsight 20/20 now I see why. Also no data for over 2 years. They finally release data, but no pictures at any conferences they have attended. Now they are stating they are abandoning all the pipeline products (see if they can partner them out) to start over and focus on immuno-oncology. No thanks, it is a total disaster. Although I have learned my lesson and moved on. Sold everything and bought better biotechs. If someone wants to invest in good biotechs try CNAT, CATB, ADXS, ARWR just to name a few good ones.
As long as CNAT hits primary endpoint in phase 2 POLT then its believable. Depends on data. I have high hopes though data will be good
THERF is licencing TaiMed's drug to sell in Canada. They don't own the full rights for it. It is being licensed from TAimed. Anyways as I have mentioned this drug can only be given intravenously which means patients can only receive treatment at a hospital or at an outpatient center that's it.
Well not that long to test in humans. But to pass a phase 1 trial at least 1 year, phase 2 trial another 2 years, phase 3 another 2 years, so a total of 6 to 8 years to get to market. But I see your point to your response to Bucky. It won't hit the market for 8 years or more.
Doesn't matter.
With TaiMed's drug you have to receive it at a hospital or outpatient center intravenously. That wont' be good for commercial opportunity at all.
Secondly look at the side effects from the trial.
Yah no thanks Pro-140 remains better shape.