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It looks like these trials have been going on 5 years. That would explain the price being down so low. This year should be a great year for them. I don't want pennies this is something to hold long term and your right the risk reward could be enormous. I don't like the gap on the chart that bothers me. Looks like it is ready to pop again hopefully we keep going tomorrow
I missed the one ending the first quarter of this year. Someone sure seems to know something here and is accumulating. Thanks for your DD. Bios are scary when it comes to FDA approval but the reports they have are well done nothing like SRPT that was a nightmare.
They have large test groups and all the data looks great and with cancer and drug resistance if this truly works it could be a huge!
Yes the stage 3 trials are going on now. I believe one will be done in July the other in Dec.Someone sure bought a lot today!
I posted the wrong links sorry here are the correct ones
https://clinicaltrials.gov/ct2/show/NCT01578655
https://clinicaltrials.gov/ct2/show/NCT01630733
Came across this earlier and started digging I believe people are buying and I see what you mean. Also I found these 2 links to update what you had before. This company has never had a split or huge volume but this was over 843.00 16 years ago. Some are talking saying this is going to be massive. Treatment for drug resistance cancer
http://oncogenex.com/physicians/custirsen-ogx-011
http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=842949
Apatorsen (OGX-427) is an experimental drug designed to inhibit the production of Hsp27, a protein that is elevated in many cancers and that has been shown to promote cancer cell growth and tumor metastasis. Hsp27 protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. Overexpression of Hsp27 has been observed in many types of cancers, including bladder, lung, pancreatic and prostate
Two trials going on now I am sure they can put together enough evidence to get the approval just a shame they didn't do it yesterday. God how quick to downgrade media loves it. This will be fine just didn't plan on waiting this long. May will go well for everyone
https://www.clinicaltrials.gov/ct2/show/NCT02500381?term=NCT02500381&rank=1
https://www.clinicaltrials.gov/ct2/show/NCT02255552?term=NCT02255552&rank=1
Yes sir sure did MM's dropping it not open to trade yet. Holding CNBC lots of attention here I am sure it will get approved. Not selling to the shorts I will wait wish I could buy more
The people on the panel had no idea how to vote on a AA I found that strange and the wording was confusing. Maybe on purpose just watched on CNBC and there is no doubt its going to hit the stock hard today.
I believe this will get approval. CEO said they would be working with FDA. No bad side effects is a big plus and it works even the board said there is no question it works.
CNBC talking on it again saying they need to approve it and need to make adjustments on the FDA approval on drugs; Claiming our process is outdated compared to other countries
I thought the presentation sucked but also thought this was more of AA and was to listen to patients which they did.., but nothing was considered as far as what the patients said. I believe if the data would have been better it would have flew straight on through. This wasn't ADCOM it was the company without a doubt. They claimed not to have enough of the drug to start a new study 2 years ago well they could have started one and brought in results up until this point. The company was a huge disappointment to say the least but its not too late these kids need the medication while the study continues they will receive it but many others have been denied. The shame is from looking at the kids and listening it works really well with No side effects. Article below
https://www.statnews.com/pharmalot/2016/04/25/fda-panel-sarepta-muscular-dystrophy/
I clicked on another video that is recent it looks like there is hope. The CEO spoke out and hopefully they will do whatever is needed to get this through the process. I watched it all day the panel was unsure of how to vote on the AA a few were very confused they never voted on a Accelerated approval. They were suppose to use the patients input too according to the new rule for AA and they didn't. We will know in May or sooner. I am holding on here
I am reading Woodcock has the final word and if this is true we might still get approval. The company was a huge disappointment, but i believe she might push it through I am not going to panic and sell this, it was left opened ended we did not get a final answer they have all the information and now we wait. Just my opinion if I can find out anything else i will post it
What a shame these lazy a$$holes thought they could come on here with lack of evidence and expect the people and the politicians to have the pull for them. How terrible for these kids
From all the testimony it works that is obvious this was heartbreaking to watch. Kids don't know the placebo effect would not work on young kids as it would on adults. I think this is the beginning and will open the gate for further research to go further. If they deny more kids will die before it can be approved in 3 or 4 years. 1st question 8 No's Not good and how can they say no they did produce data to prove this.
That is worrisome the FDA and SRPT made a mess out of the presentation. SRPT royally screwed up I could have made a better presentation than they did. Without the data its a coin toss here. They usually don't take into account what the people say but under new rules they are suppose to with accelerated approval but with data lacking I am not sure. If they deny I will bet you all hell will break loose. I know if I were there for my child I would loose it these boys are going to die and they go in there half cocked it was not very professional of the company at all! Lets hope the panel has a heart
I really believe that with all of the parents and Dr's speaking they might get the go ahead. Not because of the work of SRPT but because of the parents and Dr's. I can tell the FDA is not happy with SRPT and they have let them know that with the negatives but my God how could they tell the kids no?
This is a special circumstance for a fast track let them continue the study and let the kids have the medication. Without it its certain death at least this gives them a chance.
I know what you mean that was a kick but the patients and everyone else is giving some good points until this lady. I agree they did a terrible job laying out the presentation and this lady is killing everything they just said. If its helping the kids let them have the drug 4 years and its safe that is the main thing. #10 though how horrible but at the same time SRPT could have put this together much better and they had this extra 3 months. I sure hope they at least allow the boys to stay on meds and continue the study and hopefully they can get someone to help show them how to put a presentation together. But what they are saying is wait another 4 years to study more kids? Their lack of the ability to put this together correctly should not cost the kids like it might
The meeting is going very well honestly it looks like we might actually get the approval from ADCOM fingers crossed
I agree with you on that and many CEO's do the same thing I don't get it. This stock goes up and down and it seems to go lower each day ever so slowly its dropping 5 days left till the day we find out if they paid it or not. Hopefully its good news. I just couldn't sit here and watch it go down little by little daily so i sold until we see some positive and I just looked my God today is horrible I wonder how it will end the day its always rough.
Your welcome, here is the link for the webcast documents and the schedule for daily events. Also CNBC reporting all day on this
http://fda.yorkcast.com/webcast/Play/a6b3b94c459a4dcbb617a954382d678a1d
http://www.sac-tracker.com/pcns-20160425-bs
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM497059.pdf
Should trade again tomorrow morning
For the ADCOM and FDA meeting it goes on till 6:30pm I posted a picture of all the people that are there
16.50 already trading halts at 7am
On February 24, 2016, 38 Duchenne researchers and clinicians sent a letter to FDA in support of eteplirsen's data. The clinicians who signed that letter have collectively treated 5,000 Duchenne patients over the course of 15 years. Their scientific and medical evaluation of eteplirsen's data led them to conclude that the most scientifically robust and ethical way forward was for the FDA to grant eteplirsen accelerated approval and follow up with confirmatory trials to ensure efficacy.
On April 16, 2016, 24 Members of the United States Senate, including Senators Elizabeth Warren (D-MA) and Edward Markey (D-MA), sent a letter to FDA urging the agency to use accelerated approval and to take the patient perspective into consideration when reviewing drugs to treat Duchenne. On February 18, 2016, 109 Members of of the United States House of Representatives, including Representatives Keating, Lynch, Capuano, Tsongas, and McGovern sent a letter to FDA expressing similar sentiments.
"I look forward to joining researchers, scientists and Duchenne families in Maryland this week," said Basile. "I share their hope that the FDA will act quickly to approve a safe and effective treatment for Duchenne, and I am proud and grateful to be representing Governor Baker and all Massachusetts Duchenne families at this important meeting."
Feel free to look the report over
http://seekingalpha.com/article/3957059-sarepta-4-year-data-analysis-eteplirsen-treat-dmd
That is the truth I am all in too. One article explains how they take patients views into account under certain circumstances with a life or death situation. The last one denied had extreme toxicity the boys platelet count was way off kidney problems and numerous other issues; SRPT has none. I am 99% sure this will get approval from ADCOM tomorrow followed by approval in May. These kids have no other choice at the moment.
Good luck to us all here should be a good week. I can't believe this is going to last 10 hours tomorrow what a long day in a meeting
This is very well laid out with all of the data looks very good.., Love this first part too
Wall St. underestimating approval.
http://seekingalpha.com/article/3957059-sarepta-4-year-data-analysis-eteplirsen-treat-dmd
Thats Great! I bought at 11 wish I kept them turned around and bought back higher but I believe it will be worth it. Good Luck to you too!
I guess we will be halted all day but several people will be blogging from the meeting should be interesting. I hope we all do well with this especially the kids who need it
Maybe even more.., I sure hope everyone is right. People from all over are very positive on this. Don't forget all the shorts that will need to cover almost half of the O/S is shorted. I think it might be closer to 60. with the approval or even more this will be huge for everyone especially the kids.
With almost 45% short on this and possible approval this might hit over 50.00 it was over 40. before the FDA news knocked it down. With approval like they are predicting who knows really how high this will go. Should be interesting Monday if I were short I would surely cover. Shorts on other boards are now longs on this. Put and calls are high and few are left
Broker said it will trade Monday.., will only halt right before News!
After the 30th I might get back in but yes day trading is the best right now. I am hopefully with oil holding..,if it stayed low like last year they wouldn't stand a chance.
Most importantly this drug is safe as compared to the others that have been denied. The results are there the meeting Monday I believe is from 8 or 9am until 6:30pm. The reason they are having the meeting is because of all the letters urging the approval they will be well prepared Monday. I sold Friday with a slight profit only to buy back higher.
It looks like they might get the approval on Monday. 900 children and Dr's will be there although these kids are not in control trial the Dr's have their documentation of the progress. The halt Friday very positive that they had questions which again more positive.
Clip from article and link below that..,
"The Duchenne community will stand together Monday, understanding that there is impactful and concrete data that supports accelerated approval of eteplirsen. Together we will ask the data to be viewed, not with a sympathetic eye, but from the scientific bench, as 36 global experts did when they co-authored a recent supportive letter to the agency. In their letter, they agreed that the most ethical and scientifically robust path forward is to grant accelerated approval. The science is there. The safety is there. The approval pathway is also there."
http://www.prnewswire.com/news-releases/jett-foundation-statement-to-be-attributed-to-christine-mcsherry-executive-director-jett-foundation-300256344.html?tc=portal_CAP
No I got out so tired of up and down slowly falling lower. With BK a possibility and financials coming out next week kinda scary. Look at ETE I had it last month solid stock wish I would have stayed put sold at 7.10 with small profit hit 11.99 today. these small oil and energy are so risky I would be careful.
READ IT This is from the FILINGS Does it not say they sold stock? I am not making this up, once again i will put it in bold
As of February 29, 2016, we had assets of $ 256 , 303 including current assets of $ 184 , 865 . We have accounts payable of $197,972, convertible notes payable of $69,463, accrued expenses of $101,757. Hallmark Venture Group, Inc. is prepared to advance us additional funds as needed. Accrued expenses are for work performed by employees during the organizational and operational stages of the Company. There is no firm date for which these are to be paid. It is to be repaid when we have funds available. Since inception we have also raised $354,382 from the sale of our common stock. We believe our ability to achieve commercial success and continued growth will be dependent upon our continued access to capital either through additional sale of our equity or cash generated from operations. We will seek to obtain additional working capital through the sale of our securities. We will attempt to obtain additional capital through bank lines of credit; however, we have no agreements or understandings with third parties at this time.
My Gosh! That is from the filing read it. The O/S is never correct at the TA's seen that too many times you can call everyday and it changes they might not have record of it yet. Dream all you want but this is not as good as everyone says and after reading not just the balance sheet but reading all the paragraphs that follow and the one I posted you will see through it or not. That is why this doesn't go up and hold I am being realistic here
Why does it say this?
Since inception we have also raised $354,382 from the sale of our common stock. and then this..,
We have accounts payable of $197,972, convertible notes payable of $69,463, accrued expenses of $101,757.
Now I might not be the smartest person but I know what it says both of these statements are in there people miss this they need to read through this co is not debt free either.
This is what I would question the company sold 50 million shares (averaging the price at .007)and there is still debt its not gone. They also indicate they may sell more and then he puts in the filing O/S is 37 million. Not very creditable at all IMO. This does not include the shares sold for the convertible debt either. I was under the impression huge revenues and no debt which is far from the truth
Liquidity and Capital Resources
As of February 29, 2016, we had assets of $ 256 , 303 including current assets of $ 184 , 865 . We have accounts payable of $197,972, convertible notes payable of $69,463, accrued expenses of $101,757. Hallmark Venture Group, Inc. is prepared to advance us additional funds as needed. Accrued expenses are for work performed by employees during the organizational and operational stages of the Company. There is no firm date for which these are to be paid. It is to be repaid when we have funds available. Since inception we have also raised $354,382 from the sale of our common stock. We believe our ability to achieve commercial success and continued growth will be dependent upon our continued access to capital either through additional sale of our equity or cash generated from operations. We will seek to obtain additional working capital through the sale of our securities. We will attempt to obtain additional capital through bank lines of credit; however, we have no agreements or understandings with third parties at this time.
Thank you Nate, I came in 50% down in 2 days financials out everyone said would be huge news. Tried to find out what to expect for days no answer I felt like I was in the dark and I saw debt still showing so I chose to keep half my money which really sucked but we all know it is possible to lose it all on pinks. I just don't do well on these in fact this is the first one I bought in years and will be my last too scary for me. Good Luck to you