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.
At the Q4 conference call earlier this year Dan Meyer he mentioned that the low sale in q4 was due to that clinics would wait until Q1 2016 with new prescriptions where the J code issue was solved. Therefore, it would have been much more accurate to compare the results of Q1 with Q3 2015. Or telling how many of the BL in Q1 was related to Q4 2015 so we had a more accurate picture of the real development quarter to quarter.
He is making a spin and makes a new positive picture/story for each quarter telling that the turning point is around the corner. But, the actual numbers tells a quite different story. Both for Europe and USA.
I doubt it. For the first time we don't see words like "exited, trilled eg" in the press release.
And still, they never talk about the size of there sales organisation compared to the actual level of sale. So now they have burned up there money and done absolutely nothing about it. If they make a dilution around 50 mill. the PPS will be below 1 dollar. And what about the 25 mill fee they paid to Psivida?. They borrowed the money and they have to start paying back at the end of this year.
I only se a buy out as a possible solution - but, probably big Pharma will leat them bleed for a little longer as the company will become cheaper for every day. Lessen number one, a small company must not try to go alone a with a niche product in a big marked. The product was fascinating but the business case, lack of strategi and a sleeping management team has been a disaster.
Perhaps Fox news can help us once again ....
- Sales; $5.6 million
- Loss: $ 11.1 million ( so in the first Quarter with the J-code approval and one year after US launch.... they lose 2 dollars for every 1 Dollars of sale...)
- Cash $21. million ( which is less tha 2 quarters with the current cash flow)
- alternative or additional debt financing which it anticipates completing prior to the end of the second quarter of 2016 ( dilution)
Well - another Q with no tangible positive development and even after the long waiting J-code acceptance for the US marked.
Wonder if they are Still expecting break even in Q3 2016? - hard for me to imagine how.
This is going to be ugly today
read elsewhere that Fox news had an interview with the CEO of Alimera and introduced this as Iluvien just had been approved for the US marked. And hell - and automatic computer sales - broke out...
Dropped from $27 to $5 in less than 12 month. Trying to hit the Bottom can be a dangerous game. I believe it is hard to figure out what is going on here and if or when things will move in another direction. Last quarter results was OK.
Another very very disappointing Quarter and with a result even lower than their already lowered expectations for Q4.
They go on spending as previously and there is absolutely no link between their spending and revenues. I wonder if they have ever heard about cost cutting? Perhaps, but they definitely don't act on it.
No tangible effect on J code yet and the sale for the first two month of 2016 is below expectation. They have earlier mentioned that it will take approximately 6 months to implement J codes at customer side - so we are talking second half of 2016 before any positive effects.
No momentum regarding European sales.
Cash left for app 6 months according to the current level of cash burning.
Capital is needed. If they raise 100 mill, which is equal to 9 months of burning, the PPS will probably trade below 1 Dollar.
Any positive news at the Conference call later Today? - no, they would have pointed this out in the press release if they had anything else than the usual spin to come up with at the Cc.
They go on spending and with no selling. And even worse they don't have any plans how to handle this. Just hoping that things will turn out better next time. What a number of clowns.
To options. The first is to Sell the company if there is any buyer out there. And with a realistic price at 3 - 4 dollars Per share. The second option is to go on as usual and shareholders money will be vanished at the end of this summer.