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  • Afrezza Approval Opens The Door To Multi-Billion Dollar Markets For MannKind [View article]
    no mention of hypoglycemia and weight loss benefit in type 1; label states statistically inferior in meeting target Hb1Ac in type 1 and you call this a clean label? if not in label the company cannot make such claim - in another words won't be in their marketing materials and sales reps cannot talk about it
    Jun 30, 2014. 08:52 AM | Likes Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Sage,

    Any idea why there is such high concentration of free Dox?? 39mg of overall dose seems high if in theory the drug is to be encapsulated with liposomes.

    Thanks,
    Dec 29, 2012. 09:35 AM | Likes Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Because it simply "passed" interim analysis doesn't mean much does it?? It's simply NEUTRAL outcome. However DMC reviewing data in Sept so close to 380 PFS event and not being able to halt study for efficacy outcome increases the likelihood of negative study outcome. If the treatment worked so well it would of halted at Sept review - however it didn't, so it's likely that there will be NO treatment effect OR like I said the delta between cohorts will be clinically meaningless.
    Dec 25, 2012. 12:08 AM | Likes Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Like it or not dox has demonstrated efficacy in breast cancer and is anecdotal report of 1 single patient. If you are making your investment decision by extrapolating data from breast cancer where the drug has shown to work to HCC where it has not and let alone a single patient case - good luck to you, only makes me feel more confident w/ my position
    Dec 25, 2012. 12:01 AM | 1 Like Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    additionally chemotherapy are given in cycles usually around 6-8 cycles - and there is a reason for this it's because tumors will always regrow or progress without chemo on board. Here you are expecting to "cure" patients only giving them 1 maybe 2 treatment if their tumors are not fully ablated by RFA - goes against principles of chemotherapy treatment
    Dec 24, 2012. 09:39 PM | 1 Like Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome - Part 2 [View article]
    Great Article!

    regards to recent insider buying perhaps it's to cover their ASS so they won't be sued.

    CEO going around stating that they have found a "potential cure" in HCC is irresponsible and frankly tasteless - no chemotherapy agent has EVER shown to be curative in HCC...

    also could like to point out timing of events which makes the study highly unlikely to be positive from stats standpoint

    initially study was to enroll 600 pts with analysis at 190 PFS events

    8/3/11
    600th pt enrolled

    11/28/11
    Interim analysis failed based on 613 pts enrolled and 219 PFS events
    - all of a sudden now the company wants to increase sample size so they meet regulatory requirement in China of 200 Chinese its

    4/23/12
    at 652 pts interim analysis again fails (i will guesstimate about 260 PFS events)
    also announced 200th Chinese pt enrolled yet they continue patient enrollment

    5/30/12
    they announced 700th patient enrolled

    9/14/12
    yet another DMC review and study still not stat significant (guesstimate here about 320 PFS events)

    11/9/12
    380 PFS events finally occurs

    Based on these sequence of events if study was not statistically significant at ~320 PFS events the likelihood of positive data at 380 events highly unlikely. Even if +ve the delta between the cohorts will be minimal where the findings will be clinically meaningless
    Dec 24, 2012. 09:30 PM | 1 Like Like |Link to Comment
  • Celsion's HEAT Study: A Far From Certain Outcome [View article]
    these insider purchases were perhaps done to protect their ASS in case of civil and criminal lawsuits...

    CEO going around saying they found a "potential cure" are grounds for lawsuits and frankly tasteless - no chemotherapy has EVER been shown to be a cure in HCC...

    Also look at the time of events (CHECK PR)
    11/28/11 announced DMC review of 613 pts and 219 PFS (no benefit so continue study)

    4/23/12 another DMC review (guesstimate 250 PFS events) no benefit

    5/3012 finally enroll 700 pts

    9/14/12 another DMC review (guesstimate 320 PFS events) no benefit

    11/9/12 hits 380 PFS events

    if study was not shown stat sig at 320 events what makes you think anything different at 380 events. Even if study is +ve the delta between treatment groups will be so tiny that it will be clinically meaningless...
    Dec 24, 2012. 09:18 PM | Likes Like |Link to Comment
  • Why I Doubt the FDA Will Approve Acorda's Fampridine [View article]
    You made some compelling counterpoints and I enjoyed reading your point of view.

    With regards to your rebuttal abou the endpoint, it was only a .4fps improvement not 1.5-2 fps improvement. And this improvement was only seen in 35% of the responders. I believe that a better endpoint would have been walking improvement in all patients in the fampridine group.

    I also understand that there is a definite medical need for a drug that can help patients cope with the disability caused by this devastating disease, especially patients with secondary progressive MS. Again, if the study was designed to specifically target SPMS then I believe it will have a better shot at approval. However, this study was not designed as such, coupled with what I mentioned above will have a difficult time conving the FDA.

    I understand that you and many others have personal experiences where you have seen these drugs help individual patients. No matter how much this may sway your views about the product, it needs to taken with a grain of salt as individual experiences will vary greatly with every patient. After all, 8% of patients saw improvement with a sugar pill.


    On Apr 25 01:10 PM Richard Sater wrote:

    > I enjoyed reading your article but disagree with your conclusion.
    > I've traded ACOR a few times in the past but currently have no position.
    >
    >
    > A few points:
    > 1. An improvement of 0.5 feet per second sounds minimal to a healthy
    > person who walks 25 feet in 5 seconds (5 feet per second to 5.5 fps).
    > But a person who is only able to walk 25 feet in 16 seconds will
    > have a perceptible improvement (1.5 fps to 2 fps) and will have a
    > correspondingly greater range. A responder who goes from a walker
    > to a cane has a re-discovered freedom that leads to a greater quality
    > of life and becomes less dependent on others.
    >
    > 2. A responder rate of 35% is acceptable. Some drugs work for an
    > individual and some don't. What's nice with 4-AP is that you will
    > know within a week or two. With a background in pharmacy, how often
    > have you seen people switch from one medicine to another to treat
    > the same problem. Would they be switching if they were responding?
    > Most meds I use have a response rate of 25-75%.
    >
    > 3. This is the first drug that will be FDA approved that can actually
    > help some MS patients with primary progressive or more advanced secondary
    > progressive MS who are unlikely to respond to immunomodulatory agents.
    > This is a niche that needs to be filled and moderate response rates
    > and side effects are more acceptable when no other option exists.
    >
    >
    > 4. Side effects are acceptable. A 1% risk of seizures is high enough
    > that anyone with a seizure history will need to be excluded, but
    > others will need to understand the risk and determine if they are
    > willing to take that 1% risk for a 35% chance of benefit. The other
    > side effects (anxiety, agitation and loss of balance) are mild problems
    > that may last for hours and are not much different from somnolence
    > or dry mouth that may accompany other drugs.
    >
    > 5. I've used immediate release 4-AP in some of my MS patients and
    > have had variable success. A couple noted improved strength and/or
    > gait. Some had agitation (more likely to occur on immediate release
    > than time release) and quit and others had no benefit and quit.
    >
    >
    Apr 26, 2009. 07:13 PM | Likes Like |Link to Comment
  • Why I Doubt the FDA Will Approve Acorda's Fampridine [View article]
    meeting SPA cleared endpoint does not constitute automatic approval. Again referring to Spectrum and GPC's Satraplatin. Their phase III study satisfied SPA cleared endpoint. However the way the data was analyzed did not impress the FDA, resulting in NOT APPROVED


    On Apr 24 10:14 AM User 401371 wrote:

    > I guess you are ignoring the fact that Acorda negotiated this end
    > point with the FDA as part of an SPA before trial...
    Apr 24, 2009. 11:21 AM | Likes Like |Link to Comment
  • Why I Doubt the FDA Will Approve Acorda's Fampridine [View article]
    Even Better Doctor of Pharmacy


    On Apr 24 08:59 AM hoopdreamerz@yahoo.com wrote:

    > Are you really a Doctor?
    Apr 24, 2009. 09:12 AM | Likes Like |Link to Comment
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