RE:RE:RE:RE:RE:Opinions on this? FYI Concordia counsel said they would provide additional submissions re Donnatal to the FDA by June 30, 2015 which date the FDA accepted in their response. No idea how this gets interpreted by you and the author of the Seeking Alpha article (if different) to be a denial for delay??? So much BS. Donnatal still being prescribed last I heard more than a year later.
READ FDA response to Concordia counsel below:
Dear Mr. Allera: Thank you for your letter dated March 12, 2015, sent on behalf of your client, Concordia Pharmaceuticals Inc. (Concordia), about the hearing requests for Donnatal products sent in response to our February 19, 2015, letter to Concordia. You stated that Concordia intends to continue to pursue its hearing request for its Donnatal products, and plans on submitting additional data to Dockets FDA-1975-N-0336 and FDA-1975- N-0337 by June 30, 2015. Thank you for updating FDA with the information in your March 12, 2015 letter. Please inform us in writing if the additional data submission to these dockets is completed before June 30,2015.
GenericAdvocate wrote: ana, By their own admission on the earnings call the illegal competitor on the market in January did not take market share from Donnatal. Viberzi is taking market share from Donnatal and its taking it fast because it offers an innovative treatment for IBS.) No impairments will be reversed on these declilng drugs as you have suggested. Other impairments will just be added for more of their drugs. The OSC is forcing Concordia to recognize these impairments on their declining North American drug porfolio.
Not one analyst had the balls to answer the question that will eventually send cxr into the single digits.
Did the company supply the clinical data on Donntal that the fda had requested in 2015? Concordia responded with a request to delay the DESI hearings so they could supply the data, but accordign to a public letter on the fda access site the fda denied that request. Dr. Robert Temple is determined to get products that contain phenobarbital dropped and he has a lot of influence with the fda and the DESI hearings. Taken together with the lack of any clinical data that shows Donnatal's efficacy then this drug has a risk of being dropped without notice. The cost of such a clinical trial for Concordia to prove its efficacy would be around $100 million. They do not have this money. So where does that leave Donnatal? I think that management saying that it will be "flat" for the remainder of the year is being optimistic.
This Donnatal story is NOT a short and distort by a seeking alpha author... This is public information on the internet and the fda letters are available on the fda site. If the poster adamchess on the seeking alpha instablog is the same poster as the adamchess on this site, then I strongly encourage you to actually read an article before foolishly commenting on it.
This company is asking for class action law suits for not disclosing the current problem with Donnatal to shareholders in Q1? The class action investigation will kill them for not disclosing that a generic came on board for Viberzi in December and they did not disclose this in the Q1 conference call. Days prior to denoation day they put out a press release that the cvs drop on Nilandron will have no effect on revenue but fail to mention that a generic that came on the market that has a significant material effect on revenue? And in a previous conference call they reassured investors that they have a steady revenue stream from these two drugs? This is basis for a class action suit in itself....
...not to mention the funny accounting stuff that is going on with this company that gets them to a loss of $11.18 per share. I will not comment on that because I am not an accountand other that to say no wonder the CFO is jumping ship....
select1011 wrote: If it was before the August 3rd press release, then its WTF.
ana852456 wrote: I just wonder when they did this impairment test and how they mesured the amount.
If really illegal competitivity, we will see gain after lawsuit result.
ana852456 wrote: They said but it was material impact on their impairment test.Huge amount.
The amount of impairment is 567076.They generated in 6 months goss income almost half of this amount!!
If not new impairment test gain in next months, they will be able to pay their liabilities but not to generate gain, so the company will presente fake ration due to debt level vs total assets and they will not pay divident.
Possible settlement or nothing.We will see in media or next q3 2016
in the note of liabilities if material amount.