FDA approvals in sight? Wow, you are delusional. Only thing in sight is phase 2 data in melanoma and breast cancer, both of which would require a large phase 3 study and overall survival data to even file for approval. GBM is their best shot but phase 1 has not even begun yet. Let's be realistic here, Ziopharm is at least 3-4 years from having a product approved and that's if all the data is perfect and they move lighting fast.
And while this is a significant accomplishment, it's not the kind of news you would expect to drive the share price significantly higher. But I do think it will lead to partnering in the US which could be a big deal.
and remember who is responsible for what:
Duffy - commercialization/sales
Milby - commercialization/sales
Pfaffle - FDA interactions, CSO
Lefkowitz - financials, CFO
Then there's the 3 new people.
There is no real problem with delisting, it's tied to this derivative liability which will fluctuate with the stock price. They will eventually fix this issue but I guarantee you the company is not going to get delisted.
Ms. Tellez chairing audit committee, Mr. George chairing governance committee, Dr. P is the only "original" BOD member chairing a committee (compensation). Good to see the new folks stepping up. Let us hope they are as good as their resumes say they are.
I know it's ridiculous, I was half kidding half dreaming. Level 2 is definitely looking bullish for the first time in a long time.
It's been a long time since GTHP traded like it has the last 2 days. Maybe Cartright is working for GE and was hired to do DD from the inside, and now GE is going to acquire GTHP. Certainly seems like the perfect time for acquisition. The price is still cheap but regulatory risk has been mitigated significantly.
Not that concerned but that could be because my cost average is well under $1. If you asked me December 15th "how does $1.33 sound?" I would have been thrilled with that price. I feel horrible for the people who bought $3+ but am also confident we will get back to $3 and beyond IF these guys execute like they are saying they're going to do. It's not realistic to expect huge revs from a patient population of a few thousand in 1 country on the very first quarter. They need label expansion and they need distribution agreements in place.
added on the dip into the $1.30s this morning. Very little risk here and plenty of near-term catalysts. I think we will get news soon that will get the stock out of this funk.
Agree that would be nice to see and if we are going to see it, the next week or two is the most likely time (post 10Q/conference call). Could definitely help generate upward momentum going into FDA approval.
I thought it was a good call and continue to be very impressed with Gene. The company is in good hands.
I'm optimistic. There was a bid at $0.545 in PM but it's gone now. Would be surprised if it jumped that much.
Guess it's back to the waiting game. ~225 days max, hopefully less.
Does anyone know how OGEN plans on protecting mu1140? I was reading one of their recent filings and it looks like the original patents expire in 2017 which will be well before it's even approved. I'm wondering if they can file more specific patents on the new variants they are testing now. I sent this question to Dr. B and he delegated it to one of his associates, but so far no one has given me an answer.
This is my only concern. If they can file new IP, then I like OGEN as a long-term hold. Antibiotic resistance is not going away anytime soon, so as more antibiotics start to fail, the value of OGEN will go up and up. They should easily be able to raise any funds required to completely clinical development and the regulatory pathways for approval of new antibiotics is getting easier and easier every day.
All of Kirk's companies are getting killed. Others are SYN, HALO, FCSC...all down 50% or more in the last few months. SYN is the only one that had a good reason to tank.
I started building a position today at $1.60-1.70. It really turned quickly though before I could buy too many shares...weird. Remember only 4 months ago the stock was $4+ and management had to issue a PR saying they don't comment on abnormal trading activity? My how times have changed...