% | $
Quotes you view appear here for quick access.

MannKind Corp. Message Board

  • matese16 matese16 Apr 18, 2014 3:07 PM Flag

    FDA, timing, delays, and and and.....WHEN????

    Not trying to sound sarcastic here, not by any means. But to the question of whether the FDA can delay 3 months or 1 week or are they bound now to july 15th or could it be later or earlier and why why why........please understand fully - THE FDA CAN DO WHATEVER IT WANTS TO WHENEVER IT WANTS TO WITHOUT REGULATORY CONCERN. There are no laws or requirements that specify how long they can take for a delay. Three months is a rather common time frame the FDA uses when going with a delay, so there's nothing special there. Neither positive or negative. They could very well say 3 months and then do whatever they want. They could come out with an approval today or they can do it on july 15th, or july 16th, or june 1st, or whenever without any reason or explanation for the timing.

    Its nothing more than a calendar place holder and they can change it at will. I'm not sure why people are hung up on the exactness of the timing other than nerves and, like many of us including myself, simply want the approval in hand. However, the FDA is not bound by july 15th just like they weren't bound by april 15th.

    So anything can happen. Our current timeframe in on or before july 15th. I also suggest considering the reality of the process which many posters seem to easily dismiss. A team of FDA folks are working on the next step for MNKD as well as other drugs and projects assigned to them. They have calendars, meetings, duties, sick days, vacations, and other competing duties like other drug reviews. So while all of us are laser focused on MNKD and our approval, the FDA team is overloaded with multiple projects requiring just as much time and effort as MNKD's review and approval. So, in context, 3 months is just around the corner for them. It takes time to prepare an approval letter with post approval and labeling requirements. They can't simply go to the local hardware store and pull a letter with those specifics off the shelf. Hang tight folks...almost there :)

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • However, the PDAFA's intent is to charge a company the costs and in return deliver in a timely manner (6months) .After what they did two years ago one would've thought the FDA might expedite the process instead of this continual bleeding of the company.

    • Another good read to start off Monday a.m.

      Sentiment: Hold

    • Sure.... The FDA is overloaded with work. How many other companies hqve they been holding up for ten years... They are just like the rest of the government, too busy doing nothing.while collecting a fat pay check with lifetime perks

    • As I've said before, the FDA follows its own bylaws very strictly. Based on their bylaws, the extension in this case had to be 3 months. They really didn't have a choice at all.

    • oppie, now you are restating what i've been saying since and before adcom;
      "just be prepared for price action similar to adcom. pullback and then a move higher to levels we've previously seen.
      my hunch: partnership/terms will have a greater effect on price."
      i said mnkd will act just like vnda and chtp. i also said mths ago partnership will only be valid when we see the terms.....which should favor mnkd well :) along with an option to buy the company (but that won't be disclosed). ahhhh , we finally agree on something :) JMHO

      Sentiment: Hold

    • cobjoe872 Apr 18, 2014 8:41 PM Flag

      Matese, I and I'm sure we all understand what you are saying but our answer to you is that they have had
      at least 1-1/2 years to come up with restrictions and a limiting label of approval!!!

      Sentiment: Strong Buy

      • 1 Reply to cobjoe872
      • @cobjoe, Sorry to jump in. Agree that FDA had time to prepare label BUT I believe FDA was expecting only TYPE2 approval from ADCOM. 13-1 approval even for TYPE1 had them scrambling for more time to design the labeling for TYPE1 also. In my opinion, If FDA wanted to issue CRL, It would require even less time and FDA would have issued that in the week following ADCOM.

    • My thought is this, if you believe in the company simply sit on your shares and if the shorts push it down below 6 buy more. July 15th will come soon enough and IMHO we will be rewarded.

    • After that awesome adcomm, I'm not worried about the three month delay. However, as a working adult who has handled caseloads for more years than I care to remember, it is hard to believe that these labeling and future testing questions are not further along six months after receipt of the data. We're talking about human insulin here. Not something that needs the book re-written.
      While working for Insurance companies handling claims, we had a diary system to keep us on track. Every file would be touched or "advanced" AT LEAST once a month. There is a step-by-step process for handling claim files that gets the job done in usually less than 3 months. I would have to send out independent adjusters, obtain photos of damages, take statements from witnesses, obtain police reports, there would be competing contractors estimates to obtain and dissect, coverage determination letters, large loss reserves to request from the company. Then there was correspondence with the insured, their attorney and any other responsible parties. This was going on for a caseload of over 120 files outstanding at any given time at my desk.
      The difference here is; I was a working professional who needed my job and was responsible to my bosses for keeping the claim process moving. Who does the FDA answer to? And another thing, NEVER, and I mean NEVER did I sit on a file for 6 months without a clue where it was going and sample denial/acceptance letters at the ready.
      This group of FDA people had so obviously NOT done their DD on Mannkind's submission that everybody noticed how unprepared they were. It's the big take away from the whole affair. I only read your blogging notes but I could tell how lacking they were from all the way out here on the West Coast. It's just scary to consider that the fate of my health might ride on a group of unprepared appointees in over their heads. Six months out and....nothing. We need another 3 months. Meanwhile, how many more people will die of hypos?

      Sentiment: Strong Buy

      • 3 Replies to radgray68
      • radgray, the bottomline is we don't know the reason for the delay. it could be plant inspection related, plant expansion?, label negotiations or it could be a partner decided to introduce yet another twist. We don't know and getting upset at what we don't know doesn't do anything. So far, Al has been delivering. He's delivered a 27-1 vote - can't get much better. He has two more things to deliver - fda approval and partnership. All the others are now checked off.

      • Radgray, I don't think that it a question of the FDA sitting on this application and doing nothing with it. They did not need to do anything with it until all of the studies were complete and the NDA was submitted. Then there job was to have staff review the application and pose questions. In this case they decided that Afrezza needed an AdCom. So the question of whether they would approve it started after the information and decision from the AdCom. That was when the clock began to tick. I believe the original April 15 date was so that they could deny the NDA or issue a CRL if the AdCom was negative. Now, they have to make a decision that if they are to approve Afrezza, what will be the limitations and labeling that will be required. Also, what follow up studies would be required.
        I believe that Mannkind and the FDA are certainly in negotiations as to labeling etc. When these negotiations are completed, The FDA will announce its decision, and not a day earlier.

        Sentiment: Strong Buy

      • Here's an example: We have concerns about long-term cancer risks. Okay, lets do a 5 year post-marketing study on 1000 patients. We'll do a chest xray and FEV prior to beginning treatment, just like we require of some other drugs, with follow-up xrays every year. Done. Next question.

        But, again, I handle my affairs like a business. The FDA is NOT a business. I'd have been fired for not knowing any more than these guys knew about their file.

        Sentiment: Strong Buy

    • With that said , and I agree.. This is fifteen years in the making not to mention a one billion dollar investment.. Even Disneyland has a system to go fist... And cut the line

      Sentiment: Buy

      • 1 Reply to lenprov8
      • Understood. But the FDA doesn't concern themselves with costs, length of time in study, or anything else that most investors focus on. FDA doesn't write approvals or labeling requirements based on anything to do with sales, potential sales, etc....That's not their mission, that's the biotech mission. I don't like waiting just as much as anyone else, but to obsess (not that you are btw, but others seems to be) over every detail regarding the FDA is pointless because they aren't twisting their mustaches wondering how to mess with retail investors. They have a job to do like everyone else and theirs is a very tough job. Even with the FDA we still get drugs approved that kill people rather than help. Imagine where the medication universe would be if we had no FDA?!! I drifted way off's a friday ;)

        Sentiment: Strong Buy

    • After all that ranting, I believe you are just giving your opinion. I don't think you really know the answer as to whether or not the fda could have delayed by one month if they wanted.

      Sentiment: Hold

    • View More Messages
2.00-0.08(-3.85%)Nov 30 4:00 PMEST