This is interesting and I went over to the MiMedx page and looked around and it appears they have have a meeting with the FDA in October to discuss the letter they received. Boy looks like the lawyers couldn’t wait to get the lawsuit going form what I am reading. There’s a lot hanging on that meeting of course and who knows what the exact outcome might be as you just never know and as technical as life sciences are today it is sometimes hard to really project, at least for me the layman but again common sense tells me that at least give them a chance to meet with the FDA and then proceed. It could have been something or one small item overlooked but show those shareholder you are doing something if stock values decrease.
Who knows maybe the lawsuit will stand and maybe not. The wound healing field is definitely full of many players today and it’s something we might all need at sometime. BD
SAN DIEGO--(EON: Enhanced Online News)--Robbins Geller Rudman & Dowd LLP (“Robbins Geller”) (http://www.rgrdlaw.com/cases/mimedx/) today announced that a class action has been commenced in the United States District Court for the Northern District of Georgia on behalf of purchasers of MiMedx Group, Inc. (“MiMedx”) (NASDAQ:MDXG) stock during the period between March 7, 2013 and September 4, 2013 (the “Class Period”).
Among other things, the Untitled Letter stated that because these products were micronized – and thus had the original relevant characteristics of the structural tissue altered – they were drugs. Because MiMedx did not possess a valid biologics license, the Untitled Letter concluded the Company was unable to lawfully market these products. It stated that “[n]one of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application . . . , nor are there [investigational new drug applications] in effect for any of these products. Based on this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic] Act and the [Public Health Service] Act.”
According to the complaint, the true facts, which were known by defendants but concealed from the investing public during the Class Period, were are follows: (a) MiMedx did not possess the necessary licensing to manufacture certain of its products; (b) the Company was manufacturing certain of its products unlawfully and in violation of FDA rules and regulations; (c) at all relevant times, MiMedix’s revenues from these products were substantially and materially threatened due to the Company’s lack of licensure; (d) because a portion of its revenues were subject to termination, MiMedx’s revenue guidance issued during the Class Period lacked a reasonable basis when made; and (e) as a result of the foregoing, defendants’ statements regarding the Company’s financial performance and expected earnings were false and misleading and lacked a reasonable basis when made.
0 comments :
Post a Comment