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If a biotech has to shove failed data in the 10-K SEC Filing or other SEC filing document and don't have a press release they are attempting to hide negative news. A serious company would still issue a PR along with the SEC filing, to be nice to shareholders. The only reason not to issue a PR is to hide the fact that the study failed.
well, I like your enthusiasm that's for sure. Most others are shareholders, however, you are making the claim that because someone owns this security and have a big stake they can't critique it? Why not? They can be objective. Grip and Finesand I'm sure own a lot of shares, they have financial interest to see it succeed. But they also see that the CEO keeps pushing dates and keeps dangling carrots. I'm all for everyone (including me) having a happy ending with higher stock price, unfortunately that's not how all biotechs end up working out. There is no guarantee that this biotech will ultimately succeed. I know someone on here has bashed me already about CNAT, that's fine. That just proves my point, not all biotechs will end up working out. Some will end up in total failure and that is a reality everyone has to accept on a speculative biotech.
Bust out the bacon wrapped shrimp and champagne. But for the love of God be as happy as you can be
Oncosec just made a substantial deal and its stock has been trading much much higher. So yah I don't get what you are saying here at all you are totally wrong.
As for Conatus it was a NASH biotech and a gamble. It didn't pay off. Not all biotechs end up being successful. But I'm sure you as being some type of guru in biotech would know that.
A Seasoned CEO for CYDY would have done a reverse stock split a long time ago, uplisted to NASDAQ, got institutions on board and superior financing. But I know everyone is going to blast me for posting something not in line with pie in the sky expectations.
yes very disappointing. I was thinking that the prostate cancer data would take it higher but that didn't happen. Problem is too many are selling to make pennies. That news alone should have brought the stock to .70 cents or higher. Then the dissapointment came with the partnership announced. I thought it would be with big pharma for an upfront payment and milestones but that didn't happen. That's likely the reason for the drop. I concede to my colleagues here and will admit I was wrong. This appears to be a pure day trading playground stock.
I anticipate a partnership for rivo-cel soon for BLCM The thrive study ongoing is a market opportunity for adults in transplant worth $3 to $4 billion.
Data cut off for ESMO was April or possibly before April of 2019. THey stated they would have updated data 2nd half of 2019. If data was not ready for submission in April of 2019, there was no way for them to present at ESMO.
All it's gonna take for ADXS is updated survival data from the metastatic castration resistant prostate cancer study. If that's good? The stock price could easily triple or quadruple. Why? Because Xtandi and Zytiga are king in this area. If lm plus Keytruda beats mOS timeframe on both of these drugs, the stock will skyrocket.
Grip I agree definitely. I don't foresee approval here unfortunately. There is always an issue with the FDA. The FDA now wants this, now wants this. I think it's Nader who just doesn't know how to properly interact with the FDA. Wasn't this supposed to have received combination approval for Pro-140 back in 2018. The goal post keeps moving, it's that saying.. fool me once..... well you get the idea. I don't see CYDY surviving much longer.
P.S. This is my logical reason as to why I believe Nader doesn't want to move to NASDAQ with a reverse split. Because on the NASDAQ disclosure rules are more strict and big institutions wouldn't put up with this crap and vote him out. This is my reasoning as to why this remains on the OTC. Thanks Grip good to see someone that has a grasp on reality.
All catalysts expected in the coming days:
$ADXS Who cares or gives a .... where it closed at. The point is that 7 catalysts are expected in 2nd half of 2019. Get a clue people. You want the catalysts here they are:
1,) Updated survival data from phase 2 heavily pre-treated metastatic castration-resistant (meaning they don't respond to ADT anymore) prostate cancer patients lm treatment +Keytruda combination expected 2nd half of 2019
2,) Advaxis NEO in multiple solid tumor cancers immunogenicity and safety data expected 2nd half 2019
3.) Initiation of study Part B Advaxis NEO in multiple solid tumor cancers combining NEO + checkpoint inhibitor expected 2nd half of 2019
4,) Immunogenicity and safety data from ADXS-503 HOT in non-small cell lung cancer (Merck has biggest hold in NSCLC worth billions of dollars space) expected 2nd half of 2019
5,) Initiation of Part B ADXS-503 HOT in NSCLC study in combination with checkpoint inhibitor expected 2nd half of 2019
6,) IND submission ADXS-504 HOT Prostate cancer to begin study expected 2nd half of 2019
7,) Announcement of Investigator sponsored trial of ADXS-HPV in head and neck cancer to begin study expected 2nd half of 2019
2020 catalysts:
1.) IND Submission ADXS-506 HOT bladder cancer expected 1st half 2020
2,) Data unblinding of phase 3 halted study of AIM-2-CERV (if good could end up being partnered ) 1st half of 2020
Can you all stop the bearishness and bickering now? Thanks.
That's very easy to answer.
Because NEO and HoT are in the phase 1 portion of testing. With more immunogenicity data coming out in the 2nd half of 2019, pending results are good then they can find a partner.
As for the Lm tech in metastatic castration-resistant prostate cancer it is because the phase 2 survival data will be crucial. If survival , median overall survival, is improved over Xtandi and Zytiga/Erleada then Advaxis will 100% gain a partnership easily.
Any other questions you need answers to?
Only 3 months left in 2019, 7 catalysts expected for ADXS in 2nd half.
We got updated HOT data
updated NEO data
updated survival data phase 2 metastatic castration-resistant prostate cancer combo lm+keytruda
IND for prostate HOT
Plus many other catalysts.
Why did Medivation (MDVN) trade at .80 cents per share?
Why did Gilead Sciences trade below $1 per share?
Why did Pharmacyclics trade below $1 per share?
You get the point yet? just because the share price is down doesn't mean the company doesn't hold any value. All those I listed above were considered terrible investments and bad before they took off.
I can tell you right now that medivation dipped down because it failed an alzheimer's study with Dimebon, fell to about .60 cents per share and then after positive phase 2 data in prostate cancer surged. Going by your logic, everything fails. Your logic about market not impressed is flawed. Just because the market thinks one way doesn't mean you should be a follower. That's what separates the good investors from the bad ones.
NEO and HOT are next generation technology. Don't get me wrong Lm tech is also good as well. But NEO and HOT are stronger than Lm.
No, the reason for stopping the phase 3 was because there was no near-term value for the single AIM2CERV trial. I read the newsletter and final data for that study was not due until 3 years later. If the only value driver was 3 years later that would have done no good. Results for the cervical were not to be expected until 2022.
Since NEO and HOT had shorter catalysts (closer catalysts) and were next generation they offered more value. Not because of the money.
As I stated many times. The proper thing to do would be to reverse stock split, uplist to NASDAQ and gain strong institutional shareholders. That's how you do it. That's what a real CEO and management team would have done. There is no reason to linger on the OTC. To do what? Keep issuing warrants increasing the float to an outrageous amount of shares? That's what needs to be done, unfortunately this CEO won't do it.
Correct, it is not big pharma. Big pharma deal means quiet one and can't be disclosed in advance. For instance DRRX partnership with Gilead Sciences was a total surprise. It's definitely not a deal between CYDY and big pharma.
CEO bought 40,000 shares of BLCM the other day. Seems like partnership talk might be going well. Lots of catalysts coming up in 2nd half of 2019.
I agree, and you know how I know CYDY is shady? They don't have any cash, enough cash for the HIV programs. What do they do? Go out and add breast cancer, colon cancer, NASH, etc.
What CYDY needed to do is just focus on getting the HIV through the finish line first. Then worry about other indications.
Look, I know biotechs. They all tend to have big pipelines but difference is they trade on the NASDAQ and find solid institutional funding and have lots of cash on hand. CYDY refuses to uplist to get better capital, trades on the OTC which puts them financing with vultures and they barely have cash to get by. Why add more programs, when they don't even have the cash on hand to get the HIV product to the finish line? They gotta worry about commercialization and other issues. To me it's always been fishy why they never wanted off the OTC and now I know why. Don't get me started on the salary that the CEO Pourhassan makes, which is absurd for a company that doesn't yet make any money.
That's how the biotech game goes. Although the good news in biotech is once it happens once to you, you know how to spot these little things. For instance, I had high hopes for CNAT with its NASH drug emricasan. They pulled a phase 2 study with no placebo and listed ad hoc analysis and data mined results. Needless to say it failed all 3 studies.
In the end, it's all about learning initial studies whether or not they are done with a placebo and not data mined as you describe. NO position in this, but I'm sorry for the loss of those who lost big in this. Chalk this up as a learning lesson and just be aware of the little stuff like p-values, no placebo, data mining results. I hope NTRP shareholders recover though.
Guys I think I know why CYDY has been trading low.It's been taking forever for FDA approval date keeps getting pushed back. That's fine, the problem is that competition has been getting better in the HIV space.
Look at GlaxoSmithKline with its ViiV healthcare unit it has come up with solid viral load suppression for HIV patients by given them an injection once every 2 months. I know CYDY might appeal more on safety possibly, but while Pro140 will be taken weekly, Glaxo's HIV treatment only needs to be taken 6 times the entire year.
https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-reports-positive-phase-iii-study-results-of-investigational-long-acting-injectable-hiv-treatment-regimen-administered-every-two-months/
New updated Presentation for BLCM
https://bellicum.gcs-web.com/static-files/f68042c1-f4d9-49dc-9e37-3a50d66bea0e
It will head higher in the coming months. They have the MAA to file for rivo-cel pediatric blood disorders in late 2019 and then multi dose rimiducid for BPX-601 pancreatic cancer in late 2019. Based on these catalysts I believe the run is not yet over.
More trouble for Cytodyn, GlaxoSmithKline already advanced in phase 3 with one treatment for HIV every 2 months, which is beyond what Pro-140 achieves.
https://endpts.com/eight-weeks-between-each-hiv-treatment-gsk-notches-phiii-win-as-it-chases-ok-for-long-acting-regimen/
This stock CYDY is toast. Lawsuit will take much needed capital, company is barely hanging on by a thread.
That's what stood out for me in TYME. They have an ATM Facility they used in the past, but stated in the most recent filing that they won't touch it. Which leads me to believe they are either getting private funding or a partnership with a pharmaceutical company.
I found out that even Deciphera pharmaceuticals DCPH is also working in preclinical studies on an undisclosed kinase for cancer metabolism. It looks like TYME is paving the way, but the leader in this space right now. More biotechs probably to follow soon after. Good thing is that Tyme has plenty of patents protecting its type of kinase cancer metabolism.
If they start the two phase 2 pivotal studies in the coming weeks, along with the final prostate cancer data, I can easily see TYME at $9 per share +
Between also someone caught which I found on the 10-Q SEC filing report that TYME doesn't intend to use its ATM for financing in the quarter ending September 30, 2019. To me that signals they have another type of financing deal lined up. Either private financing, loan, or possibly big pharma partnership with upfront payment/milestones/royalties. It's in the SEC filing:
https://www.sec.gov/Archives/edgar/data/1537917/000156459019030424/tyme-10q_20190630.htm
"The Company has historically funded its operations primarily through equity offerings of its common stock. Previously, on November 2, 2017, the Company entered into an equity distribution agreement (“Equity Distribution Agreement”) with Canaccord Genuity Inc. (“Canaccord”), to commence an at-the-market offering (the “ATM Financing Facility”) pursuant to which the Company may, from time to time, sell shares of the Company’s common stock, having an aggregate offering price up to $30,000,000, through Canaccord, as the Company’s sales agent. In the year ended March 31, 2018, the Company raised approximately $6,152,000 in gross proceeds through the ATM. During the fiscal year ending March 31, 2019, the Company raised approximately $5,844,000 in gross proceeds from the facility. At June 30, 2019, there remained approximately $17.9 million of availability to sell shares through the facility. The Company does not intend to utilize the ATM Financing Facility in the quarter ending September 30, 2019."
Correct, TYME has already shown good results in 2 different types of cancer. Lots of catalysts coming up, about 5 in 2nd half of 2019.
let's be honest here, this stock is not going to reach $2 or $3 per share on a BLA announcement. With all the good news it has now it is still sitting at .42 cents per share. It will take a reverse stock split to bring CYDY over $2 or $3 per share. Add to the fact that the amount of outstanding shares is enormous, I don't see it happening.
Tyme is up after-hours by 30% because Rexahn's REXN pancreatic cancer trial dropped in ORR from 38% down to like 23%. It used RX-3117 in combination with abraxane and it did bad. That's why TYME was up so much after hours.
Okay, I think they typically do a pre-announcement. all biotechs do that.
They will say " so and so.... will report earnings on August 21, 2019" for example a few weeks or one week beforehand.
.0032 is an awesome outcome. The failure point for studies depends. It can either be 0.01 or 0.05. If you see any trial achieve a p-value over those values in context the drug is a dud. A .0032 is awesomesauce.
How do you know that's real? They haven't released earnings yet. I don't see any press release from the company. They would have announced /pre announced. I think that's fake.
He used to be with the company, but no longer is. He retired in April of 2019. But you are right the constant selling is bad on his part. Especially with 5 catalysts approaching.
He has no inside info anyways so his sells are just probably programmed in every week.
Nice, maybe we get 1 of the 5 catalysts expected in the 2nd half of 2019.
https://www.tymeinc.com/investors/news-releases/press-release-details/2019/Tyme-Technologies-to-Present-at-the-39th-Annual-Canaccord-Genuity-Growth-Conference-on-August-7th-2019/default.aspx