The misinformation that spreads across this board is simply amazing. The company is NOT awaiting “approval” of the NDA!!! They are awaiting its “acceptance”. Once “accepted”, if “accepted” they then will be waiting and burning through cash for an additional 10 months at least for the FDA’s decision whether or not to “approve”. I am convinced that a CRL waits at the end of that new AEZS rainbow. Now that everyone knows what was behind the inundation of brainless pumping prior to the offering and that my track record for being the most accurate poster on this board as to what this company does next (for two years running now), what do I feel will happen next? Quite simply what has always happened with this stock. They will spend through their newly gotten money without producing one worthwhile development. Turpin will still be issuing shares through the ATM to keep the stock pinned down while increasing his yearend bonus. Ergomed has still not contributed one thin dime of the $10 million they promised, nor will they until they have made more than 10 million on running the clinical trial for AZ-108. And David Dudd, the new CEO responsible for shareholders losing an additional 50% of their value, past the 90% losses that Engel provided them, will feel as though he is still meeting all necessary “objectives”. He obviously has a ……… “well if shareholders have no bread then let them eat cake”……. Attitude, blinded and protected by his own outrageous salary and horrific management of shareholder value.
This company is a dilution trap that is courted by the sleaziest of toxic financiers. The executives are some of the highest paid in the industry, and their track record towards shareholders is one of the worst. Look at a long term chart. Better yet review all of my past posting history. Especially when I am contradicted by the resident long term pumpers on this board. While you’re at it why not also review the posting history of the resident long term posters. Then ask yourself who would pump this company incessantly and then constantly post about all of the “accumulation” taking place, other than someone who was on the company’s own payroll? Truly one of, if not “thee”, sleaziest biotech companies traded in the public sector. Anyone touching their stock are left with a slimy residue that eats away their investment value like atomic acid. Meanwhile Dudd and Turpin will be receiving nice big fat bonuses for their part in shareholders losing an additional 35% of their value last week. It is how the CEO and CFO of this company have always flown together. Beware those who argue otherwise.
Not new to AEZS, about three years following and quite well vesrsed in biotech research with 25 years pharma and biotech experience. I am confused though, as tho why you are here on this board, or even care what happens to this company if you are convinced it is such a bad investment. Just go away and spread your knowledge elswhere.
AEZS-130 is a small niche test. The company is going to need a lot more than that in order to sustain itself. The company has been a total failure as an "investment." It's history speaks for itself. That's why until proven otherwise, I say at best it's a trade. No offense to anyone. Best of luck
That because you got in way too early and have been burned.
When it comes to little biotech companies like theses it's better to be a little late than way too early. You should know that going in!
This "niche test" is performed at about 200,000 patients annually based on a non approved procedure called "ITT" = Insulin Tolerance Test. Doing an ITT with a patient means to bring him into a extraordinary and potentially dangerouse situation by application of Insulin until the patient gets a hypoglycemic condition (below 40 mg glucose/dL blood), which is associated with anxiety, tremor and has to be closely supervised by a doc. This ITT procedure lasts about 3-4 hours, costs about 2,000 - 3,000 usd. Furthermore and most essential this procedure is prohibited for patients with comorbidities (stroke, cardio-vasc risks, diabetes, poor general condition at elderly people, ....). So a lot of patients can not be tested today and I think that the number of procedures could be expanded from 200K up to 300k - 500 k with an easy AND SAFE test procedure like Macimorelin.
Such numbers can easily be transfered to a revenue potential. Take 300K tests at 500 usd per test and you get 150 mio usd. Take 50 mio shares outstanding and you will find yourself at 3 usd revenue potential/share. Take it x 3 and you get a price target of 9 usd. Thats NOT pure phantasy! Take this number x 3 for the EU and Asia market - although far ahead the road.
hope this helps
Sentiment: Strong Buy
Nothing last forever.. The company either gets approval or they don't. Until then they have to pay their bills with stock just like every other little biotech company. You people should know this before buying!!!!!!!!
Concerning your statemant of waiting for a "CRL" I would like to remind you that Macimorelin Phase III trial had a SPA with FDA and all efficacy and safety criteria have been met or exceeded. This is the reason to think that an approval is almost given. Where would be the red herings for a CRL? Efficacy? NO, PIII SPA criteria met. Safety? NO, PIII SPA criteria met. So what do you talk about concerning waiting for a CRL?
Sentiment: Strong Buy
All about Semantics, submits/ filings NDA, 6 Months or Less for FDA decisions. It depend on how busy FDA will be. Right now they're busy approving Drugs to the Marketplace....FDA trying to meet the demand, they're faced with Old Drugs and Shortages
I think his opinion is far away from beeing honest. Why? Either he is uninformed or willfully didn't mention that Macimorelin has already assigned orphan designation with 7 years of market exclusivity and a FDA agreed SPA. Furthermore it possesses the worldwide rights for Macimoreline and therefore could (and should) seek a development partner for EU and another one for Asia/Pacific. Both partnering deals would bring in sufficient cash for at least 1 year each and together with the latest offering they are easily financed for 3 years.
Sentiment: Strong Buy