AEZS paid them to do the report as iGXT did a couple of weeks back.
No, you are wrong. Once a new supplier is signed, only then will the FDA decide on a class 1 or 2. According to one poster, he called RDHL and they are expecting a class 2 response. When will they find a suitable supplier? No one knows. could be another months.
We should see 4 ANDA approvals in the next 12 months.
He didnt mention the MAA that will be filed in Q3 and will take 10-12 months. Further, he didnt mention ED from what I saw, and it requires one more study. Then the NDA.
IMO, no one knows about the FDA and ED re timeline. Everyone is guessing. Also, the PAR ANDA - it will take a min of 2 years from the filing.
It is the only thing in the company worth anything.
It's not easy to read through the NRs to figure out exactly what is happening. But from what I can see it is more about the raw materials than a new manu.
The company says that it is beyond their control but who selected the supplier and werent they screened?
Finally, you can forget about RDHL. I thought they would provide some info but in fact they refused to any answer any questions. I asked them the ave time for a EMA approval and they said it was confidential.
Migraine for the US market - 3rd party manufacturer and the best guess is a few months... my guess is Sept/Oct
Migraine for Europe - All studies performed and app being completed.. submission in Aug/Sept with approval 10 months later
ED - one more study and then NDA in Q4 this year with approval 10 months after that
PAR - with ANDAs it is anyone's guess
Hypertension - no idea
With IGXT being the manufacturer and collecting royalties, this drug itself could add $0.40-0.45/share in EBITDA in 2015.
The est for anit-migraine was 40-50c eps prior to the dilution. After that, I think the top is 40c. However, I dont know if Cleland's est was the US market only.
As for the news yesterday, I would say that we are a big step closer to EMA approval. We will see the app in Q3.
They would know better than me... but I would think late 2015. As for the ED pivotal study, I thought it was going to start in June and take roughly two months.
The average time taken by FDA to approve a drug product was 322 days, while the European medicines Agency (EMA) took 366 days and Health Canada (HC) took 409. The data also show FDA to have the lowest floor for drug approvals, potentially allows drugs to be approved much faster than any other regulator. Novartis AG’s anti-cancer drug Gleevec, for example, was approved in fewer than 80 days by FDA.
This was particularly interesting given the differences in regulatory review styles exhibited by the agencies, noted the duo. EMA approved 96% of all applications during the first review round, while FDA and HC approved just 62% and 69%, respectively, during the first round of review. “You might think that extra requests for statistical analysis, data collection, or even new clinical trials would make the FDA process more time-consuming than that in other countries, but it doesn’t,” observed the researchers.
RDHL/IGXT have been working on the EMA for a while now, and it is my understanding that the study announced today is the final item needed. RDHL said they want to submit in Q3 or roughly AUG/SEPT. I think the average review time is 8-10 mon. So I hoping the launch in Europe will be in 2H15.
So now they are cleared for the EMA... they say the app will be in Q3... should get FDA approval in Q3 as well.
I have a lot of faith in PAR and have to think if they will launched the products they will get a min sales fig. I thought the other dosages will be launched this month?
That data is vague but seems reasonable.... 15 and 30 mg tablet rev are now averaging 1.5 mil$ in rev per month... later this month, sales for additional dosages will begin and my best guess is that rev will rise to 2.5 mil/mo. With 23 mil shares outstanding, we are looking at 1.3 $ in sales per share going forward and roughly 1$ EPS.
Lots of cash... and more coming...
They have over 5milUSD in cash now and thus, I have little worry about dilution. They had 4.7milUSD in rev during Q1 and with the launch of new dosages (late in Q2), Q2 and Q3 should show sig growth in rev.... but how much? New partnerships?
June 30 - results of study for migraine then submission to EMA
June/July - ED study results then NDA (then EMA?)
Sept/Oct - Approval by FDA of anti-migraine
Any update from the PAR projects?