Biotech Values

[DewDiligence]

Re: Exenatide LAR
(from NSTK ymb):

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Re: Exenatide LAR...Dew
by: DewDiligence 03/09/06 03:56 am
Msg: 49628 of 49635

>Dew, please explain your reasons for suspecting LAR might be delayed, or otherwise discontinued.<

I’m not implying that LAR will be discontinued. However, I find that the amount of time that has elapsed between the end of phase-2 and the announcement of firm plans to initiate phase-3 is excessive for a drug with a large financial consequence to AMLN.

Surely, AMLN and LLY must have deliberated at length about how a phase-3 trial for LAR ought to be designed long before they got a positive signal in phase-2. Moreover, it’s hard to attribute the elapsed time since phase-2 entirely to a backlog at the FDA: the Agency can be slow, but it is rarely that slow. Further, the companies have not stated that they submitted a request for an SPA, so evidently they have not. Why haven’t they?

Finally, AMLN has served up a red herring to explain the delay: that they are considering a 505b2 pathway. It will make little practical difference whether 505b2 is used for LAR because AMLN already owns the clinical dossier for Byetta and is free to include any and all Byetta data in support of the NDA for LAR regardless of whether the NDA is submitted under 505b2.

It may turn out that AMLN and LLY are doing nothing untoward, but for now their actions do not quite ring true for me. Regards, Dew

[Posted as a reply to: Msg 49627 by javajim01]
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