I'm not trying to find my way to the FDA's heart. I'm doing an honest assessment and trying to figure out why the CE Mark takes 6 months and the FDA process for the same product takes 4+ years. Is it because the FDA cares more about the safety of American's than EU regulators care about Europeans? I don't think so. FDA is way too fickle and they get away with it. They can change their mind whenever they want with no accountability.
I think the FDA is doing okay when it comes to NDA/BLAs. I just find the PMA process in particular incredibly painful and controlled by whimsy and politics instead of science.
And my experience is contrary to what you are saying about CE Mark. Take CorMedix for example, CE mark was obtained July of last year, product was sold in December of the same year. Sure there is some additional paperwork for certain countries but you can at least be assured once you have the CE Mark, it's just paperwork. You're not going to get the CE Mark and then France is going to say "we want to see an additional 500 patient clinical trial."
LuViva is the best screening tool out there. If I'm GE or some other large device maker, why not buy GTHP, run the 10,000 patient pivotal trial required to get Luviva approved as a primary screening tool, and then you have a unique device which no one else has which will become the standard of care? Seems like an investment of maybe $200M would allow a large company like GE to establish themselves as the dominant force in screening for cervical cancer.
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.
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.
Every time I see news of the Roche PCR test in the media, GTHP drops. People don't get it. The PCR test gives a positivity rate of 2-10%. Plenty of those are false positives. This is where Luviva comes in, to confirm or reject the PCR test. Really....Luviva should be a primary screening tool but GTHP just doesn't have the resources to conduct the 10,000 patient pivotal trial that would be required to achieve that.
a month since last PR and the last few PRs were all about additions to the BOD. It's been 4 months since we had a PR that was meaningful on the business side. Hopefully these guys have been hard at work and soon news will start to flow.
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.
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.
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.
Neither of you, the FDA will do whatever they please. Seriously though, I think it's likely to be some where in between. They're not going to walk out of the meeting and say "okay you're approved" but given that they've reviewed the application numerous times already, it's not going to take 180 days.
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.
Agree, been buying here and there since $2.30. Added heavily today and yesterday at $1.55 and $1.65. News should start to flow in the next few months and new 52-week highs will be here before we know it.