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BioMimetic Therapeutics Inc. Message Board

  • investwize999 investwize999 Dec 30, 2011 1:00 PM Flag

    May be the last chance to buy before approved

    before 10 to 20 per share

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    • $6 would be nice already...

    • Review of panel discussion (this thread) shows how Augment was given a rotten deal at the start. One particular panel member, a new FDA appointee from the private sector had very strong ties to competitors.

    • Why would you want to delete your last comment regarding the 30K shares sold by the corporate attorney?

    • Let us be clear:
      Nothing is resolved in these trials unless there is an agreement with the FDA. If there are any adjustments or whatever in the trial period, it is with FDA approval. If there is no FDA approval on any aspect re the trial, then the trial results will not likely be approved. Further, if there are any problems relating to any trial results, the FDA has a responsibility to let the company know if further tests or trials are required. This is a "material" event.

      Since there have been no additional tests or trials required as per the "material" event requirement and since the company has been compliant in all aspects re their trials to whatever the FDA has has required and then some, then it would seem reasonable to conclude that the FDA should rule favorably on Augment bone graft. Whether there are additional considerations to be followed up on is another matter. As long as the FDA gives marketing approval, then that is what is important and not all of the fantasies of what might need to be resolved.

      This procedure has been a farce. The product is safe, it is efficacious, it is as good as any other procedure, ie., it is non-inferior.

      I think that it will be approved in the EU and here in the U.S. If it is approved in the EU before the U.S. it will show the hypocrisy of the FDA with regard to a valid scientific product.

    • "I don't understand the $15-$20 valuations in the short term that people claim" If FDA approves, I think 15-20 is the minimum because....

      1) Injectable augment faces a lot easier road to approval. The studies have already been adjusted as per FDA communication after the recent meeting; see 10Q.
      YES SAMPLE SIZE WAS ADJUSTED TO 300 MAINLY TO ADDRESS THE POOR STATISTICAL POWER IN AUGMENT TRIAL-NOT TO MAKE THE SAME MISTAKES AGAIN

      2) The stock traded around 11-15 from 10/09-3/11. Now if approved, augment is that much closer to US market and EU approval.
      THE TWO KEY WORDS HERE ARE "IN THE SHORT TERM" AND "IF APPROVED". IN THE THE SHORT TERM GIVEN THE CURRENT MACRO ENVIRONMENT CAN THE STOCK REACH 15-20 IF PRECLINICAL LIKE PK STUDIES ARE NEEDED AND DISCLOSED IN THE FDA LETTER?

      3) Augment is supposedly a $1 billion product.
      AGREED, BUT WHEN APPROVED. THE QUESTION IS IN WHAT TIME FRAME-1 MONTH, 3 MONTHS, 6 MONTHS.

      Unless... they raise cash before approval. I still think approval by March is possible. IS APPROVAL POSSIBLE NOW IN JAN BEFORE JP MORGAN? THEY ARE SHOWING UP HERE-THEY PREVIOUSLY SAID NO CONFERENCE TILL FDA LETTER

      If management didn't think approval was likely, don't you think we would see early stage clinical trial plan? THEY WOULD NOT RE-DO ANY CLINICAL TRIALS FOR AUGMENT AS AUGMENT INJECTIBLE WOULD HAVE TRIAL DATA BEFORE A NEW TRIAL FOR AUGMENT IS COMPLETED. Management was confident enough to alter injectable trial, but not start a new augment trial. FOR THE REASONS MENTIONED ABOVE-IT MAKES NO SENSE TO DO A NEW AUGMENT TRIAL SINCE INJECTIBLE TRIAL IN CANADA IS COMPLETE AND US INJECTIBLE ENROLLMENT IS UNDERWAY.I don't think management is confident enough with injectable augment to write off (surgical) augment yet. AGREED

    • "I don't understand the $15-$20 valuations in the short term that people claim" If FDA approves, I think 15-20 is the minimum because....

      1) Injectable augment faces a lot easier road to approval. The studies have already been adjusted as per FDA communication after the recent meeting; see 10Q.

      2) The stock traded around 11-15 from 10/09-3/11. Now if approved, augment is that much closer to US market and EU approval.

      3) Augment is supposedly a $1 billion product.

      Unless... they raise cash before approval. I still think approval by March is possible. If management didn't think approval was likely, don't you think we would see early stage clinical trial plan? Management was confident enough to alter injectable trial, but not start a new augment trial. I don't think management is confident enough with injectable augment to write off (surgical) augment yet.

    • I am not sure twelvetooth. That's why I don't understand the $15-$20 valuations in the short term that people claim--I sure hope they are right. Any major data submitted to FDA in eight months becomes material and need to be disclosed to the public. I am not sure if they can submit or address anything NEW till they get the formal letter. They can only prepare themselves to have the data upon understanding that the FDA will require it. They were not successful in developing the neutralizing AB test that the FDA required of them as of May 12th as they saw PGDF Absin high amounts in Augment group but not in control. This concerns pregnant women as neutralizing PGDF Abs can affect naturally occurring PDGF in fetuses causing fatal birth defects. One possibility could be approval with restrictions on the label--not to be given to patients with preexisting cancer or pregnant women--which increases cost for additional testing and screening and would not prevent off label use which the FDA is concerned about. To be honest, NO ONE really knows how this might FLY. This is a tough one. Others in this board say with confidence it will approved. I wish I could share the same optimism. I hope I am wrong--best case scenario I see--approval after more data.

    • The FDA set them up, maybe they weren't pleased with the slim trial and the company's reliance on GEM to win the day. Enables the FDA to apply pressure. I expect the company has responded in the eight months that have passed, to what extent and success is a mystery.

      Will longs stay the course?

    • Yes. That's why I don't think it's a slam dunk. The clinicians all voted YES, but the PK and statisticians voted NO with the premise further testing and PK testing for PGDF and its half life needed to be done. Our only hope is since GEM21 is approved by the FDA, there is no reason why they could disallow this product albeit with further testing. The question is not whether it will be approved--which it will, but how soon. Thanks

    • Thanks,respond/matri (how many IDs have you). Haven't read the entire May 12th DOC of 333+ pages but will. Dr Au and the other pharmacologists/oncologists are showing an abundance of caution in my opinion. For unknown reasons, the FDA withheld All of the GEM data, and the non-clinicians were suspicious. From the limited data they were presented, long term cancer concerns could not be addressed. Au's remark about PDGF degradation referred to the protein that somehow escaped into the mouth, she was not shown any info pertaining to the surgery site. Yes, they felt the study was not large enough to properly access the product, but over a dozen years of GEM data was missing, WHY ?

      Politics plays a role in these outside advisory panels. For some unclear reason, the FDA did not permit the panel to see the public published GEM data.

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