hopefully -I'm a bigger psdv fan, but I think there is money to be made in both - I have many more shares in psdv - this was an entry purchase - if they drop further when they raise cash, I may dollar cost average .."may" ...
yeah, I realize and at one time thought I would wait for cash raise first - but at this price I'm hoping like you that it is at least partially built in. still own a lot of psdv and prefer it to alim, but both can do well from these prices...
Welcome aboard. I've owned ALIM for about a month. Your timing was better than mine, but I think the future looks bright for both of us.
and why are we financing again? Shouldn't we have been profitable 2 yrs ago? Oh, I know.. shttymgmt. Maybe they need some cash for their class action suit that is inevitable.
A few questions in all candor: What happens after the 3 year period of treatment expires? Is the tiny piece injected into the eye removed or does it stay there? If the patient wants another 3 year injection, is another piece inserted without removing the first one? How about after 15 years? Will there be a virtual junkyard in the users eyeball?
Kool, We do know they need cash. I don't know where they'll get it exactly, but I hope it's not dilutive at these prices. I've picked up some Alimera shares this week for the same reasons you've mentioned here. Iluvien will be a cost effective management tool for half of all DME sufferers; it's just that simple. In another year or so it will be generating 150M /yr. in sales. Period.
after watching this company self implode over several years, I've finally bought some shares. The stock is too cheap and the clinical results are compelling. Sales should finally pick up over next several quarters. I just hope they don't find a creative way to mess things up again for shareholders. ...glta
Very interesting! A product like Iluvien, with second-to-none efficacy, huge convenience advantages, huge compliance advantages, and better safety overall, deserves a much broader label.
Sentiment: Strong Buy
wonder why they currently are looking for a submission specialist... Guess they soon will announce a resubmission of an NDA and with a much broader labelling build on the real world data :-)
Prepare, submit and maintain the regulatory affairs operations associated with electronic regulatory submissions, including navigational publishing, preparation of eCTD sequences and submission through various health authority portals. Maintain a thorough understanding of FDA, EMA and ICH guidances for submission processes, which may include additional international health authorities. Accountable for maintaining effective systems for regulatory document management and electronic submission filings.
ESSENTIAL DUTIES AND RESPONSIBILITIES
40% Submission coordination activities, including individual document navigational publishing, eCTD sequence building and electronic submission.
30% Responsible for Regulatory Information Maintenance system and all records associated with all dossiers.
20% Actively work with regulatory team(s) in other offices in the production of sequences for submissions to appropriate dossiers.
10% Assist with Regulatory Assessments as they pertain to electronic submissions.
Other duties and projects as assigned.
EDUCATION & WORK EXPERIENCE
Bachelor’s degree with 1-3 years of experience in regulatory submissions publishing. Technical and comprehensive knowledge of publishing and sequence building required. Strong knowledge of FDA, EMA, ICH and Health Agencies guidances and regulations for electronic submissions. Possess excellent planning and organizational skills, time management and communication skills, both written and oral.
WORK ENVIRONMENT & PHYSICAL DEMANDS
General office working conditions which may, at times, be fast paced and stressful. Moderate to extensive travel may be required including international destinations.
ALIM has an extremely attractive product and increasing sales going for it, and thus decreased risk, so I'm hopeful they can eliminate any dilution.
Sentiment: Strong Buy