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$SYN - The $heff effect! For once I bought in before you at $2.79. I just knew you were going there too!
$heff, As we come to Christmas and New Years of another year of investing I just wanted to be the first to come forward this year and thank you for what you have done. I have had a good year and I know many others on this board have. Your constant study and willingness to share has been a positive influence on all of us again.
Merry Christmas, Happy New Year
The Panda
Someone on tha Yahoo boards said Punit tweeted that Merkel Data would not come until the first half of 2014...
http://finance.yahoo.com/mbview/threadview/?&bn=deaf8eed-7d4e-3e9e-8004-c66f510cb300&tid=1387478003597-f99d6e24-c778-45cd-906f-6f8b16e88045&tls=la%2Cd%2C4%2C3
Then jump in, the water is warm!
Blowing through the .41's
Like the way this stock is holding its gains despite being at or near 52 week high. Makes you feel better times are still ahead.
It almost seems like everyone has given up on seeing Merkel Cell data in 2013. I am not so sure we won't see it yet this year. Yesterday's news was good. Merkel cell data could make for a jolly christmas.
Pre Market looks shiney!
Just a couple positive thoughts for the day:
You have a promising treatment that has shown documented results against one of the nastiest forms of cancer (Merkel Cell) with ongoing clinical trials and soon expected results.
You have an Executive Director of a fortune 500 (57 or 58) leaving to come work for a little podunk upstart pharma wannabe. Probably being given a boat load of stock options in lieu of millions in cash.
The aforesaid makes a statement such as ...
"We stand at a transformational moment in oncology. I'm convinced that intralesional therapy with IL12 drives systemic anti-tumor immune responses and has the potential to augment immunomodulatory therapies such as anti-PD-1."
Just gives you a good feeling IMHO.
Most importantly let's hope for a viable treatment for the sufferers.
Looks like Good news. Seems like a heavy weight in the field joining a pretty small outfit. That says something IMO. He must feel good about the technology.
Not to mention at clinicaltrials.gov as well. We may see something by years end.
Here is a good article if you haven't already seen it.
http://ascopost.com/ViewNews.aspx?nid=7369
Yeah I got you there. Seems every time this company has a conference that the price rides upward going into it. Then, when the conference happens, price goes south.
That is all I was saying. It seems to be somewhat predictable behavior. The news is the conference ... this afternoon.
Fortunately low volume. EOM
The old axiom - sell on news. News is anticipated so people are selling. I don't think this is unexpected behavior. We'll see where it stops.
Found this and it is fairly descriptive of the process.
http://smart-therapeutics.com/DrugPipeline/RareNeglectedDiseases/FDAOrphanDrugProgram.aspx
So the question to ask Amy would be ...
Is their Immunopulse procedure for Merkel Cell classified as a "Orphan Drug".
Obviously if it is then there a significant benefits that arise going into approval. From what I have read, I don't believe it is so classified. But who knows ...
Good luck tomorrow. Hopefully they release meaningful data.
There is no defacto about it. My understanding is that the FDA has a specific "Orphan Drug" fast track program where they speed through the approval process for only certain "promising" drugs. You have to apply to the FDA for this status. The Orphan Drug designation is highly sought after because it gives the company a leg up on every one else and it has a clear anticipated path to approval. That is why I am questioning the ongoing dialogue. I would expect this stock to be trading at a much higher value if it had this designation.
Either way I like what I see so far of this company. I just want to make sure the ambiguity in the discussion is addressed. That's all. Not bashing the stock or anything. Not real happy with the performance of the share price but that is another matter. I am hoping for good results this month too! Otherwise I wouldn't waste my time here and I would busy be trolling Sheff's board for the next hot one.
Would be very interested in hearing Amy's response to your question. Please post her response.
Disagree. It says "orphan drug status" nowhere in these slides. Merkel Cell Carcinoma is orphan status - meaning no approved treatment for it. There are other orphan status diseases such as Pulmonary Fibrosis. And there are drugs that hope to be certified by the FDA but there are no "Orphan Drugs". There is a specific filing process for that.
A drug has to be approved as an "Orphan Drug" by the FDA for Orphan fast track approval. There is no Oncosec Orphan designated drug as best I can determine from any of this literature. I hope I am wrong, but I do not believe I am.
It does not say it is an "Orphan Drug". It says Merkel is a "Orphan disease" meaning there is no approved drug for its treatment. That is different than having FDA designated "Orphan Drug" status which is essentially a fast track to approval.
Sure I agree. But the FDA issues that designation and I am not sure Oncosec ever received it. If you hear otherwise please let me know.
Not downgrading anything ... Dude ... I own a fair share of this stock. I just never saw anything on Orphan Drug status. Perhaps you should reflect on the purpose of this board ... dude!
Maybe, where can I find this orphan drug designation? I checked the website and could not find it anywhere. I am just asking.
Yeah, sorry lasers. I can't find anything either. I have looked all over too. Nothing on Orphan Drug status. That would be a big deal.
Where is this suggestion of an Orphan Drug coming from? I don't remember hearing anyone mentioning a filing for consideration as an Orphan Drug. Did anyone from the company mention this? Further, is this even eligible as it is just a treatment method, not an actual drug.
What a dud! It has been a month and not a peep. Oncosec must be on vacation. They commuted their test results and left us all second guessing.
184K plus on the bid! Good sign.
Not liking the price action on this stock. The blog didn't exactly have a big impact.
There is a new BLOG on the oncosec website
Yes, I sure did. She has been responsive in the past and I expect to hear back from her. Unfortunately there is only so much she can offer as we all know. I would just like to see a little more info on progression of the studies. I wouldn't be here yapping if I wasn't upbeat about the company though.
I also tried to contact them on this and I have not yet heard back from them. They should update their web site if that is the case. Again, I am long on this but I would like to see a little more responsiveness from them. I think they are awfully quiet and it concerns me.
Yes, let's hope the data is positive. I am long as well. You have to be a little concerned though that they are advertising their milestones to happen between 8-15 and 10-31 and yet here we are in the second half of October and we have not heard peep on three separate milestones. Seems like they may be stringing folks along just a little.
Is this a really big deal? This is not a big dilution folks. Look the financial statements indicated that this was inevitable. They indicated they did not have enough cash all along. Its not like they are printing a couple hundred million shares. Let's not forget the catalysts going forward and the positive indications we have seen already. There potentially is a lot more value here than there new market cap will represent in my opinion.
Very sorry $heff
It's called selling on news. It always seems to happen and it is not a big deal. If you believe in the technology and the long term prospects here then you see that $35 Mill or so market capitalization is a little on the light side. Why sweat the one day spikes of a promising new technology? Just my honest opinion.
DARA heating up
DCTH $1.60 Nearly 1.9 Milllion shares already traded.
Good reading ... Got this out of $heff's forumn
http://seekingalpha.com/article/1040611-hemispherx-biopharma-a-voice-of-reason-amid-the-din?source=yahoo
NAVB CRL