Tuesday, 11 February 2014

Any questions? Anyone? Anyone?

Oh yes, thanks, hi, I wanted to ask a couple of questions regarding today's second quarter results and update.

1. It's disappointing to hear that Igloo might not fully recruit this Northern Winter. Actually I think a PCR positive rate of 50% is pretty good if the study is recruiting from family practices, rather than ERs. Also, you said that it takes 2 weeks for a PCR result? We'd expect a PCR result in a day or two down under.

Also highlights one of the problems in flu treatments in primary care without rapid flu diagnostics. Can we get into the rapid flu diagnostic market again?

Is the use of 2 different dosages of LANI part of the problem regarding sample size?

Also you mentioned going back to Barda? You mean for more than 250 million? 

In any event, isn't it the FDA you need to speak to regarding the recruitment?  Is there a mechanism to discuss Igloo with FDA before deciding to extend it, other than submitting an NDA?

Also, doesn't the sample size depend a bit on results? If the benefit of LANI is better than expected, might that mean no extension is required? Can you analyse interim results to determine this?

Also, putting the study back another year reduces the patent life of the compound doesn't it? Or are there extensions possible?

2. Why does the company need to do another Phase 1 and 2b study for vapendavir? It has already spent over 10 million on a Phase 2b for vapendavir in asthma. Why do you need a "new" tablet formulation? Is the new tablet form worth starting from scratch? How much do you expect to spend?

Isn't there a similar problem regarding rapid rhinovirus diagnosis? Can you develop such a test if you want funders to eventually reimburse this compound?

3. Is the restructuring complete?

4. Have you had any face to face meetings with Daiichi Sankyo regarding the ROW arrangement regarding LANI? When do you expect to be able to announce an update on this issue?

5. How many analysts are now covering Biota?

Thanks




1 comment:

  1. I'm scratching my head as well:

    1. The company received advice from Pharma in the design of Vapendavir's Phase 2b, targeting mild to moderate asthma sufferers. The new team now says a commercial opportunity exists for moderate to severe asthma suffers lol.

    2. The old team didn't undertake a trial to test Vapendavir's drug interactions. The new team is. Hmm.

    3. Are they looking at tablets to better target the pediatric market? I suppose the cost might be justified if they were looking at a rapid disintegrating tablet.

    4. Given the types of infectious diseases Biota specializes in, this issue of recruitment rates and diagnostic tests will hound us in future HRV and RSV trials as well. Oh joy.

    et.

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