You are resigned to bankruptcy and 1 in a 100 odds?
My neighbor is doing some experiments in his basement - wanna invest $25K with him?
1. Isn't the total fentanyl market $400M in the US? 5% would be $20M.
2. I would take anything that Ahn says with a grain of salt.
3.. Let's assume that Abstral does $14M in 2014. That would be about $8M in the second half. Abstral quarterly expenses for manufacturing, marketing, sales ,,,, are $5M to $6M quarterly. So how will it be profitable? Isn't GALE required to run a post approval trial too?
Don't you have to allocate some of the overhead and management compensation to Abstral? Is Ahn just subtracting the cost of goods sold to project profitability?
GALE's fundamentals are shaky. It's an open question if GALE will be able to recoup its $30M outlay for Abstral before the patent expires in 2019.
It's hard to be confident about the Neuvax trial since the patients are a subgroup from a failed trial.
Why place your bet on a company run by management that can't be trusted. Even if the market cap were $60M, I would have reservations, but $300M?
There are no other biotechs? I can probably come up with a dozen that have comparable market caps or even a lot lower, with late stage drugs or approved drugs.
What's the infatuation with GALE. Management screwed shareholders, why hang around and support and defend them?
Find a little self respect.
You can't defend the insider sales. I have never before seen insiders en masse dump nearly all their holdings. If that's not a red flag, then what is? But all you have to do is look at the pps now.
What re-entry? They haven't bought back any shares. The re-entry by awarding themselves millions more free options and then selling the shares again?
They will get a double benefit. By knocking the pps down they were able to award themselves lower priced options while shareholders took huge losses.
(the $5 drop in the pps means that shareholders took a hit of over $500M)
You are raving about the puny Abstral sales that are generating losses. Sure, when you start at zero, the quarterly sales will show increases.
when the are done unloading.
FDA resubmission; the latter part of June.
I prefer using comparables, as in real estate, to determine valuations.
The closest comparable to GTHP is EXAS.
They too are waiting for FDA approval. This is their first go around with
the FDA, so chances are they will receive a CRL.
EXAS has inferior "pooper scooper" technology, a diagnostic test for colorectal cancer.
You know, scoop some poop, mail it to a lab and wait for the results.
EXAS has a market cap of $1 billion.
A renowned medical practitioner Bayo Windapo of the Polybond medical services has said that cervical cancer is curable if it is detected early.
The doctor made this known at the 2014 Health intervention programme held in Lagos by Human development Initiatives (HDI), a not-for-profit, non-governmental organization working to safeguard the reproductive rights and health of women (particularly widows), children, adolescents and youths.
Dr Windapo who spoke extensively on cervical cancer introduced a new technology in cancer detection called Luviva. Luviva is designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers. LuViva is designed as a fast, painless test that - unlike Pap smears and HPV testing - does not require a tissue sample or the delay of laboratory analysis.
"Early detection of cancer and precancers greatly improves survival, and LuViva is designed to help preserve the reproductive health of women" Windapo said.
LuViva uses proprietary technology to identify cancers and precancers quickly by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.
Other highlights of the events include; Health screening (Blood Pressure Check, Temperature, Urine test 'Urinalysis', Height and Weight check), Diabetes test, HIV test, consultation and counselling, treatment of minor ailments with available Over The Counter (OTC) Drugs and referral of cases for expert management as necessary.
Here's what you need know:
Abstral is generating losses.
Neuvax will fail as all cherry picked trials fail.
Combo trials rarely succeed.
Preclinicals aren't worth mentioning.
All that you have is hype.
How much is hype worth?
I checked the FDA website. Here is the answer: the FDA has 45 days to review the filing to determine if it is complete. When that review is finalized and the filing is acceptable, the PMA is considered filed on the date that the review is completed and the 180 day period starts tolling then. So the 180 days period is firm but the reason that the decision is made after 180 days from the date that the filing is submitted to the FDA is because the PMA is not considered filed until the FDA completes the - up to 45 days review. So in essence, the FDA has up to 225 days to make a decision if the full 45 days are taken to determine the acceptability of the filing.
"The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.
FDA will refuse to file the application for substantive review if a PMA application does not meet a minimum threshold of acceptability. If the information or data are presented unclearly or incompletely or are not capable of withstanding rigorous scientific review, FDA may consider the PMA incomplete and not file it. If FDA refuses to file a PMA, FDA will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number. FDA will advise the manufacturer of what information must be provided, or steps to be taken, to make the application fileable."
45 days from today gets us to June 30th and then 180 days is 6 months, so that is by Dec 31.
How do you get, possibly early 2015?
Is it 180 calendar days or 180 business days?
Didn't GC say within 45 days, so that would mean less than 45 days and the FDA response would most likely come in early to mid December?
If an offering for a few million shares is placed with an underwriter now, it would be priced at about .30 plus additional warrants. GTHP is an illiquid BB stock. The hedge funds would only buy shares at a steep discount. NASDAQ stocks do offerings at an average 10% to 20% discount range. The problem with these offerings is that the hedgies sell short at the market price and cover with the discounted shares from the offering. They pocket a tidy profit while shareholders take it on the chin as the pps is pushed down to the discounted offering price or lower.
Perhaps Gene has connections and can do a private placement at a smaller discount. If GE bought 10M shares at .40, that might be viewed as a positive. But any dilutive offering at these low prices really sucks. Debt or a joint venture is the only viable route.
Dilution is bad. It's not so bad if there is dilution after the stock price runs up. Dilution could be good if shares are sold for more than equity per share.
The reason many are antsy about dilution at GTHP is that the pps is low. It's at a ridiculously low price. If dilution came now, it would probably be at around 30 cents per share. The impact of dilution now would be devastating to shareholders. Let's say hypothetically that $30M were needed. At 30 cents per share, 100M shares would have to be sold, thereby increasing the shares outstanding from 66M to 166M, or 150% and making GTHP a permanent penny stock. If dilution can be held off until after a positive FDA meeting and the stock runs up to $1, the dilution would "only" be 30M shares. If dilution can be held off until after FDA approval, there is a mandatory exercise of warrants at $1.50.
Hopefully, Gene realizes that you can't dilute at the present time, at this low share price. A loan, even at 20% would be preferable, to tide us over until FDA approval. Even before approval, positive LuViva sales would also increase the pps and dilution then, at a higher pps, could be used to pay off the loan. The other option is a joint venture, partnership or marketing agreement for an upfront payment. Small biotechs do partnerships all the time. You are giving up some of the revenue but a deep pocketed pharma with marketing channels and a sales force can roll out the product faster and capture a larger market share than going it alone. So you might be giving up some of the revenues to the partner but the partner is bringing in more revenues than you would have been able to get on your own.
This will be a test of Gene's management skills. Can he get us through this rough patch without massive dilution or will the downward spiral continue, that the prior management perpetuated, with dilution at lower and lower prices?
1) Patient enrollment for a Phase 3 trial of Neuvax hasn't even been completed. It will be a while before the cherry picked patient trial inevitably fails.
2) GALE hasn't developed any promising drugs, it bought other companies reject drugs of the junk heap. A pipeline of other peoples trash is no pieline.
3) Abstral sales are pathetic. Orexo tried marketing it for 2 years and sales only reached one half of one percent of market share. So along came a sucker that paid $7M for it. The first two quarters had combined sales of $2M which reflected "shelf stocking" at pharmacies. Look for sales to continue to be microscopic and generate large losses until the patent expires in 2019.
4) Gale-401 is not even worth talking about. Mills insiders running for the door tells you all that you need to know about it.
5) Herceptin/NeuVax 300 is sure to fail. Trying to show that a drug that doesn't work on its own will work in combination with another is an exercise in futility.
6) Collaborations in third world countries are equivalent to no collaborations. It's just window dressing. It's name dropping to impress the uninformed.
7) Patents are expiring soon or are limited. The Abstral patent expires in 2019. The Neuvax patent expires in 2015. The prior owner of Neuvax got a limited method of use patent specifically on the cherry picked patients until 2028.
8) GALE never marketed anything. The sales staff i composed of recent hire-ees picked up off the street. Look for the Abstral sales to continue to be sluggish and to generate large losses until patent expiration in 2019.
The list goes on. Don't forget: if insiders don't believe in the company and ran for the door, why should you? It's never a good idea to hold shares in a company run by sleaze bags. A SEC INVESTIGATION is under way. It was announced by the Company in the 10-K filing.
Based on the facts listed above, this DreamTeam PUMP & DUMP company run by sleazoids is OVERVALUED. You want nothing to do with it.
Disregard analysts, seeking alpha and message board pumpers, and you'll be just fine.
Analysts upgrade stocks AFTER they run up on good news.
Analysts downgrade stocks AFTER they tank on bad news.
There were no downgrades when GALE was at $7.77, they will come below $1.50.
Analysts associated with underwriting firms put out strong buys to try get the business or after a secondary to allow the hedgies to sell as fools rush in.